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更新于：2026-09-08
Ioflupane-I-123
碘[123I]氟潘
更新于：2026-09-08
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 欧盟 (2000-07-27), |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构/序列
分子式C18H23FINO2 |
InChIKeyHXWLAJVUJSVENX-HFIFKADTSA-N |
CAS号155798-07-5 |
关联
22
项与 碘[123I]氟潘 相关的临床试验NCT06828705
Establish the First International Database on Semi-quantitative Values Obtained in Scintigraphy With Datscan® in Cadmium-Zinc-Telluride (CZT) Camera (VERITON-CT)
Datscan scintigraphy is a nuclear medicine examination allowing the diagnosis of neurodegenerative pathologies linked to damage to dopaminergic pathways, such as Parkinson's disease (essential for the differential diagnosis of essential tremor).
开始日期2025-07-30 |
申办/合作机构- |
NCT04564092
A Phase 1, Non-randomised, Noncomparative, Open-label Study to Assess the Safety, Biodistribution, and Internal Radiation Dosimetry of a Single Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers
This is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label, single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and effective dose of DaTSCAN™ ioflupane (123I) injection in Chinese Healthy Volunteers.
开始日期2021-05-13 |
申办/合作机构 |
NCT04193527
A Multicentre, Phase 3, Clinical Study to Compare the Striatal Uptake of a Dopamine Transporter Radioligand, DaTSCAN™ Ioflupane (123I) Injection, After Intravenous Administration to Chinese Patients With a Diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, or Essential Tremor and to Healthy Controls
This is a multicenter, open-label, non-controlled, non-randomized, phase 3 clinical study to compare the SPECT findings after a single IV administration of DaTSCAN™ ioflupane (123I) injection for patients with a clinical diagnosis of Parkinsonian syndrome (PS) involving striatal dopaminergic deficit (SDD; specifically, Parkinson's disease [PD] [SDD], multiple system atrophy [MSA] [SDD] or or progressive supranuclear palsy [PSP] [SDD]) as compared with patients with a clinical diagnosis of essential tremor (ET) (no SDD) and age-matched healthy controls.
开始日期2020-06-28 |
申办/合作机构 |
100 项与 碘[123I]氟潘 相关的临床结果
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100 项与 碘[123I]氟潘 相关的转化医学
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100 项与 碘[123I]氟潘 相关的专利（医药）
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346
项与 碘[123I]氟潘 相关的文献（医药）2026-06-01·JOURNAL OF NEUROLOGY
Mapping of motor and non-motor symptoms to 12-region dopamine transporter single-photon emission computed tomography in Parkinson’s disease
Article
作者: Yoshimaru, Daisuke ; Yuzawa, Ami ; Okano, Hirotaka James ; Ozawa, Masakazu ; Ishii, Kenji
BACKGROUND:
Parkinson's disease (PD) is a neurodegenerative disorder characterized by the loss of nigral dopaminergic neurons, which substantially influences the severity of motor and non-motor symptoms. However, the relationship between the regional patterns of striatal dopaminergic loss and specific clinical manifestations remains unclear, as many prior studies relied on global or coarse regional measures without hemispheric resolution or adjustment for handedness. We comprehensively analyzed clinical features in relation to dopamine transporter single-photon emission computed tomography (DAT-SPECT) uptake across 12 atlas-based subregions in a large cohort.
METHODS:
We analyzed baseline DAT-SPECT data using 123I-ioflupane in 591 drug-naïve patients with PD and 120 healthy controls from the Parkinson's Progression Markers Initiative. DAT-SPECT uptake was quantified in 12 anatomically defined striatal subregions. Associations between regional DAT-SPECT uptake and motor and non-motor symptoms were examined using multivariable linear regression models adjusted for age, sex, handedness, and imaging site, with false discovery rate (FDR) correction. Group × region interaction analyses were performed to assess disease specificity.
RESULTS:
In patients with PD, motor symptoms were associated with reduced DAT-SPECT uptake across widespread striatal regions, with right-predominant involvement. Hyposmia was selectively associated with dopaminergic loss across all putaminal subregions, whereas the caudate regions were unaffected. Cognitive performance was associated with the left pre-ventral putamen. No region demonstrated FDR-significant associations in the healthy controls, and several symptom-DAT-SPECT relationships showed significant PD-specific interaction effects.
CONCLUSIONS:
12-region DAT-SPECT mapping revealed symptom-specific topographical patterns of striatal dopaminergic dysfunction in drug-naïve patients with PD.
2026-05-01·Clinical Case Reports
Geriatric Depression Mimicking Parkinson's Disease: A Case of Levodopa‐Responsive Pseudoparkinsonism With a 3‐Year Follow‐Up
Article
作者: Toda, Masashi ; Nabeshima, Yoshihiro ; Nakamura, Yohei ; Imaizumi, Kenshiro ; Watanabe, Tetsuya ; Goto, Junichi ; Oyamada, Suzuha ; Yamashiro, Sachi ; Hirazumi, Koki ; Isoda, Kazuya
ABSTRACT:
Geriatric depression often presents with psychomotor retardation. Severe psychomotor retardation may manifest as pseudoparkinsonism, which mimics Parkinson's disease (PD) and is often difficult to treat with standard antidepressant therapy. We report a case of a woman in her 60s with recurrent major depression with melancholic features who remained symptomatic despite several months of vortioxetine augmented with aripiprazole. She developed overt parkinsonism, including asymmetric rest tremor, rigidity, bradykinesia, and postural instability, requiring wheelchair assistance (Hoehn and Yahr stage 5). A diagnostic trial of levodopa produced marked improvement in both motor and depressive symptoms, leading to a presumptive diagnosis of comorbid PD. However, a subsequent dopamine transporter scan (DaTscan) showed normal striatal uptake, which argued against neurodegeneration. The final diagnosis was considered most consistent with geriatric depression with pseudoparkinsonism. During the 3 years of follow‐up, her depressive symptoms showed a clear temporal association with levodopa: symptoms worsened after discontinuation and remitted after reintroduction. This case highlights that pseudoparkinsonism in geriatric depression can closely mimic PD and that DaTscan may help exclude neurodegenerative parkinsonism. These findings also suggest that levodopa may be considered in selected cases of difficult‐to‐treat geriatric depression with pseudoparkinsonism.
2026-05-01·Japanese Journal of Radiology
Accelerating imaging: deep learning for enhanced 123I-ioflupane SPECT efficiency
Article
作者: Yamashiro, Tsuneo ; Misumi, Yuka ; Iizuka, Hitoshi ; Haga, Akira ; Takano, Shoko ; Aso, Shinjiro ; Kato, Shingo ; Horie, Keiichi ; Utsunomiya, Daisuke ; Aoki, Ryo ; Ishiwata, Yoshinobu ; Aritome, Kazuhiro ; Takeuchi, Yuka
Abstract:
Background:
Conventional
123
I-ioflupane dopamine-transporter SPECT requires 25–40 min of acquisition, causing patient discomfort and limiting throughput. This study assessed whether deep-learning (DL) reconstruction can yield diagnostic-quality images from a 5-min scan.
Methods:
We retrospectively analysed 207 studies (1035 slices) obtained between April 2018 and June 2020. After cropping to 64 × 64 striatal regions, 600, 185 and 250 images from 120, 37 and 50 patients were used for training, validation and testing. Six convolutional architectures—U-Net (one–five depths), V-Net, U-Net + + , R2U-Net, Attention U-Net and TransUNet—were trained to translate 5-min into virtual 25-min images. Image quality was assessed with peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM), analysed by Friedman and Dunn–Holm tests. A blinded reader study involved three nuclear medicine physicians grading 50 cases (100 striata) on a four-point scale; agreement with the 25-min consensus was measured by weighted κ and intra-/inter-observer intraclass correlation coefficients (ICC).
Results:
All DL reconstructions significantly outperformed raw 5-min images in PSNR and SSIM (p < 0.01). The four-layer U-Net achieved the highest quality (PSNR 32.7 ± 1.7 dB, SSIM 0.842 ± 0.069), ≈1.8 dB and 0.13 higher than baseline, and statistically indistinguishable from 25-min images (
p
> 0.05). Reader concordance improved from fair with baseline (κ = 0.29–0.41) to substantial with the four-layer U-Net (κ = 0.62–0.70); intra-reader ICC was 0.84–0.93 and inter-reader ICC 0.73–0.75.
Conclusions:
A compact four-layer U-Net restores diagnostic fidelity to 5-min
123
I-ioflupane SPECT, enabling an 80% reduction in scan time without loss of quantitative metrics or interpretability. DL-accelerated protocols may enhance comfort, reduce motion artefacts and increase throughput, warranting prospective multicentre validation.
19
项与 碘[123I]氟潘 相关的新闻（医药）2026-08-10
欢 迎 关 注
引用本文：高菲，李钰莹，成伟华. 阿尔茨海默病与帕金森病PET示踪剂临床转化研究进展[J]. 中华神经医学杂志, 2026, 25(7): 713-721. DOI: 10.3760/cma.j.cn115354-20260104-00001.
作者：高菲1 李钰莹2 成伟华1
作者单位：1国家原子能机构核技术(放射性药物工程转化)研发中心，中核集团放射性药物工程技术研究中心，原子高科股份有限公司；2北京师范大学放射性药物教育部重点实验室
摘 要
正电子发射断层扫描(PET)示踪剂具有高灵敏度和可定量等优势，能够在临床症状出现前发现与阿尔茨海默病(AD)、帕金森病(PD)相关的分子病理改变，为疾病早期诊断、鉴别诊断及疾病修饰治疗提供重要时间窗。近年来，除氟[18F]脱氧葡萄糖-PET反映脑葡萄糖代谢改变外，通过靶向β-淀粉样蛋白、tau蛋白、α-突触核蛋白等病理蛋白以及多巴胺能系统和神经炎症相关靶点的PET示踪剂也取得了较大进展，推动AD和PD分子影像从定性显像逐步向疾病早期微量病理负荷定量评估的转变，并在临床诊断和疗效评价中展现出重要价值。本文围绕AD和PD相关PET靶点，系统梳理代表性示踪剂的临床转化现状及其局限性，以期为神经退行性疾病的早期诊断、疗效评估及新型PET示踪剂开发提供参考。
前 言
神经退行性疾病(neurodegenerative diseases，NDDs)是一类以神经元进行性损伤及突触功能障碍为主要特征的慢性疾病。随着人口老龄化加剧，其疾病负担持续上升[1]。阿尔茨海默病(Alzheimer's disease, AD)与帕金森病(Parkinson's disease, PD)为两种代表性NDDs，二者普遍起病隐匿、早期临床表现缺乏特异性，且个体间疾病异质性突出。
AD病理改变涉及β-淀粉样蛋白(amyloid-β，Aβ)斑块沉积、tau蛋白过度磷酸化及神经原纤维缠结(neurofibrillary tangles，NFTs)形成，同时伴随乙酰胆碱能系统损伤、神经炎症、氧化应激以及金属代谢稳态失衡等多重病理过程。近年来，针对Aβ的单克隆抗体药物，如阿杜卡单抗[2]、仑卡奈单抗[3]以及多奈单抗[4]等，在临床试验及临床转化中取得重要进展，已获美国食品药品监督管理局(Food and Drug Administration，FDA)批准上市；其中，仑卡奈单抗[5]和多奈单抗[6]已获中国国家药品监督管理局(NMPA)批准上市。上述Aβ靶向治疗药物的获批及应用，使AD诊疗由症状导向转为病理靶点驱动，强调了早期诊断和适宜治疗人群筛选的重要性。
PD病理特征则主要包括α-突触核蛋白(α-synuclein，α-syn)聚集、线粒体功能障碍、多巴胺能神经元凋亡和神经炎症等[7]。目前，与AD更强调治疗干预窗口前移不同，PD急需解决的是早期诊断和鉴别诊断困难的问题。PD早期临床症状常与多系统萎缩(multiple system atrophy，MSA)、进行性核上性麻痹(progressive supranuclear palsy，PSP)以及原发性震颤(essential tremor，ET)等疾病存在重叠，传统临床诊断方式在早期识别及与非典型帕金森综合征的鉴别方面存在明显局限[8]。随着PD治疗策略从传统多巴胺能向以α-syn为靶点的疾病修饰疗法转变，进一步凸显了早期精准诊断和鉴别诊断的重要性[9]。
正电子发射断层成像(positron emission tomography，PET)可利用特异性放射性分子探针，无创、在体并高灵敏度地可视化特定病理生理过程，实时定量评估病理蛋白沉积，神经递质系统功能、神经炎症及脑代谢改变等。相较于主要反映脑萎缩等相对晚期结构改变的传统影像手段，PET能够在细胞和分子水平揭示疾病相关功能异常与病理负荷变化，是实现NDDs“分子活检”的重要技术手段。在AD领域，Aβ、tau及神经炎症等PET显像有助于其病理确认、疾病分期和疾病修饰治疗的疗效监测[1]；在PD领域，靶向多巴胺能系统、α-syn及神经炎症等的PET示踪剂则有望提高其早期诊断和和非典型帕金森综合征的鉴别诊断能力，并为疾病进展评估和新型治疗策略开发提供客观依据[7]。本文系统梳理近年来AD与PD领域PET示踪剂的研究进展，总结相关PET示踪剂的临床转化现状、应用价值及现存挑战，以期为NDDs的精准分期、鉴别诊断、疗效评价及新型PET示踪剂开发提供参考。
一、靶向AD和PD相关靶点的PET示踪剂
围绕AD与PD的核心病理改变及相关功能异常，PET分子影像已形成覆盖糖代谢改变、病理蛋白沉积、多巴胺能系统、突触完整性和神经炎症等多种疾病相关病理标记物的示踪剂体系，包括靶向Aβ、tau蛋白、α-syn、多巴胺能系统、突触囊泡蛋白2A(synaptic vesicle glycoprotein 2A，SV2A)以及转运蛋白(translocator protein，TSPO)等代表性PET示踪剂。与AD和PD相关的主要PET靶点及代表性示踪剂见图1，代表性示踪剂的基本信息和临床转化应用见表1。
1. 糖代谢类PET示踪剂：氟[18F]脱氧葡萄糖([18F]fluorodeoxyglucose，[18F]FDG)作为临床最常用的PET示踪剂，被誉为“世纪分子”，可通过定量细胞内葡萄糖代谢水平来反映组织器官的功能状态，目前已广泛应用于肿瘤、神经系统疾病的诊断与评估[10-11]。其中，[18F]FDG PET能反映NDDs特征性代谢模式，AD患者的典型表现为双侧颞、顶、额叶葡萄糖代谢下降，该检查诊断AD的灵敏度与特异度可达76%和82%[10]。
2. Aβ靶向PET示踪剂：AD核心病理特征为脑内Aβ于疾病早期即发生异常沉积；当Aβ沉积负荷随病程进展累积至饱和水平后，其沉积量不再随临床症状恶化而进一步升高[12]。其常见的亚型为Aβ40或Aβ42。与健康个体相比，AD患者体内Aβ产生和清除的平衡被打破，使得大量的Aβ在脑内聚集，形成富含β-折叠结构的聚集体，从而产生神经毒性[13]。11C-匹兹堡化合物B([11C]PiB)是由Klunk等[14]合成并报道的首个应用于人体的Aβ-PET显像剂。它对各种形态的Aβ斑块具有高亲和力和特异性[15]。有研究表明，[11C]PiB皮层保留指数与尸检所测的Aβ负荷密切相关(r=0.78)，且在脑内的非特异性滞留较低，表现出良好的灵敏度和准确性[16]。因此，凭借诊断准确性，[11C]PiB目前已成为临床检测Aβ的“金标准”。然而，11C核素约20 min的短半衰期使其仅能作为医院制剂使用，无法商业化推广。相比之下，具有合适半衰期的18F(t1/2=109.8 min)更适于商业化生产与临床推广。与此同时，18F还具有较低的衰变能、成熟的制备工艺、良好的生物兼容性及丰富的标记方法，使其成为当前应用最广泛的正电子核素[17]。
基于[11C]PiB结构优化获得的18F标记探针氟[18F]美他酚([18F]Flutemetamol)，通过在苯环N-甲氨基邻位引入18F制备，其对Aβ的结合亲和力较高，抑制常数(Ki)值为0.74 nmol/L，略优于[11C]PiB(Ki=1 nmol/L)，但由于脂溶性较高，仍存在脑内非特异性摄取量偏高的问题。氟[18F]贝他苯([18F]Florbetaben)为二苯乙烯类衍生物，对确诊AD患者的脑匀浆中Aβ具有较高的亲和力(Ki=6.7 nmol/L)，能够较好区分AD患者与健康对照者，但其在脑白质中的非特异性摄取高[18]。为降低探针脂溶性，研究者进一步发展出苯乙烯基吡啶类衍生物氟[18F]妥西吡([18F]Florbetapir)，但该探针同样存在脑白质中的非特异性摄取量较高的问题。目前，[18F]Florbetaben(FDA：2014年3月[18]，NMPA：2023年9月[19])、[18F]Florbetapir(FDA：2012年4月[20]，NMPA：2025年6月[21])和[18F]Flutemetamol(FDA：2013年10月[22])已获FDA或NMPA批准。在最新发表的1万余例大样本队列中，对这3种Aβ-PET显像剂的临床视觉阅片结果与定量结果一致率进行比较，结果显示[18F]Flutemetamol与[18F]Florbetaben的一致率分别为89.0%和87.9%，高于[18F]Florbetapir的85.4%[23]。这一结果提示，尽管上述3种显像剂已实现临床转化并广泛应用，但在低负荷或边界性Aβ沉积的识别中仍可能存在视觉判读与定量结果不一致的问题，反映出其检测敏感度仍有提升空间。为进一步降低脂溶性，提高Aβ检测灵敏度，Li等[24]在二苯乙烯结构上通过引入2个N原子，形成二芳基双腙衍生物，设计合成了新一代Aβ-PET显像剂氟[18F]贝他嗪([18F]Florbetazine)；该示踪剂对Aβ纤维具有高结合亲和力(Ki=10.1 nmol/L)，在AD患者脑切片中具有较高结合能力。Wu等[25]进一步证实[18F]Florbetazine在各脑区对Aβ的摄取模式与金标准[11C]PiB高度一致，且[18F]Florbetazine可在15 min内实现AD患者与健康对照者100%的鉴别，具有灰/白对比高于1.3的显像优势。目前，[18F]Florbetazine在我国处于III期临床试验阶段，有望成为国内首个具有自主知识产权的Aβ-PET示踪剂。同样为了降低白质摄取的新型示踪剂还有[18F]Flutafuranol，亦称[18F]AZD4694或[18F]NAV4694，其作为一种苯并呋喃骨架的Aβ-PET示踪剂，具有与金标准[11C]PiB相似的化学结构，但对Aβ纤维亲和力更高[解离常数(Kd)≈2.3 nmol/L]，且脑白质中的非特异性结合低，灰/白信号比优于传统探针，头对头临床试验显示其脑内分布与[11C]PiB高度一致，可100%区分AD患者与健康对照者，目前[18F]Flutafuranol在美国及欧洲开展III期临床研究，有望成为新一代Aβ-PET示踪剂[26]。
3. tau蛋白靶向PET示踪剂：AD的另一核心病理特征是过度磷酸化的tau蛋白在神经元内聚集成NFTs[27]；其负荷随疾病进展而递增并饱和，且与临床症状呈现良好的相关性，因此，活体监测脑内tau蛋白水平可作为评估AD严重程度和进展速度的关键指标[28]。tau蛋白缠结病理特征为含亲水性侧链环绕的楔形口袋，对带电荷或氢键供体/受体基团结合倾向。2020年5月，氟[18F]妥西吡([18F]Flortaucipir，亦称[18F]-AV-1451)成为首个获FDA批准的tau-PET示踪剂[29]。Flortaucipir属咔唑类衍生物，与tau双螺旋丝(PHF)结合，并且与PHF的Kd值为0.57 nmol/L，可用于评估认知功能受损成人患者脑内NFTs的密度和分布。然而其在脑内存在明显的脱靶结合问题，可能干扰图像阅读，限制了其在非AD tau蛋白病诊断中的应用价值。在对额颞叶痴呆患者的研究中，首次联合应用[18F]FDG、[11C]PiB和[18F]AV1451进行PET显像，分别评估糖代谢、Aβ和tau蛋白沉积，全面揭示了不同脑区的代谢状态和病理改变，为额颞叶痴呆与AD的鉴别诊断提供了影像学依据[30]。然而，该研究中18F-AV1451探针同样表现出明显的非特异性结合，且存在对不同tau蛋白亚型亲和力不足等局限性，影响临床适用性[30]。
为克服上述问题，研究人员通过化学结构优化，在提升对病理性tau蛋白选择性的同时降低与非靶蛋白的结合能力，设计合成新一代示踪剂，包括[18F]MK-6240、[18F]GTP1、[18F]izaFlortaucipir([18F]PI-2620)以及[18F]RO948。其中，[18F]MK-6240为氮杂吲哚衍生物，作为新一代tau-PET示踪剂的杰出代表，与NFTs中PHF具有高亲和力(Kd≈0.2 nmol/L)[31]。尸检放射自显影显示，其与tau蛋白缠结结合模式与Flortaucipir高度一致，表现出对tau沉积较高的特异性和选择性[32-33]。在一项纳入不同认知状态的受试者的前瞻性研究中，同时联合[18F]Flutemetamol、[18F]Flortaucipir PET显像和磁共振成像，对受试者Aβ、tau蛋白和脑部结构改变进行多模态评估后发现，tau蛋白沉积是认知功能下降的最敏感指标，优于Aβ和脑结构改变，而Aβ累积则特异性地与记忆延迟相关[34]。上述结果表明，多靶点、多模态影像可从不同层面揭示疾病状态，对AD的早期诊断和分期发挥关键作用。此外，氟[18F]唑洛妥([18F]Florzolotau)在中国已完成用于AD诊断的III期临床试验；其在4R tau蛋白疾病诊断方面也有一定优势，可推动非AD型tau蛋白疾病结合通路的早期诊断与精准分型[35]。
[18F]PI-2620探针通过调整分子骨架的刚性和平面性，凭借其独特的硫代喹啉并吡咯核心结构，在保留对AD相关3R/4R tau蛋白高亲和力的同时，显著降低对单胺氧化酶(monoamine oxidase，MAO)的亲和力，有效避免了脱靶结合；同时[18F]PI-2620在非AD tau蛋白病中也展现出巨大潜力，能在PSP患者脑中特异性显影，并有效区分PSP与PD[36]。[18F]PI-2620与[18F]DOPA联用，可有效实现PD中各亚型的分型鉴别[36]。[18F]GTP1与[18F]RO948作为咔唑类衍生物，可通过降低酸解离常数、增加极性表面区(polar surface area，PSA)及刚性桥环设计，进一步缩短PET扫描时间至30 min，并减少基底节中的非特异性滞留，为tau蛋白病的早期筛查、纵向随访和疗效评估提供了更高灵敏度、更优信噪比和更低辐射暴露的影像学工具[37]。
4. 多巴胺能系统PET示踪剂：在PD的病理进程中，位于黑质－纹状体通路突触前膜的多巴胺转运体(dopamine transporter，DAT)是其最早、最显著的分子损伤位点。[99mTc]TRODAT-1是首个用于DAT显像的99mTc标记显像剂，制备简单、易得，可以获得较好的图像分辨率，但血脑屏障通过率低、特异性低等缺点限制了其广泛应用[38]。为提升显像性能，目前多种高选择性DAT-PET显像剂已成功开发。在评估多巴胺能系统的放射性示踪剂中，托烷衍生物构成了一类重要的核医学显像剂。以碘[123I]氟潘([123I]FP-CIT，DaTSCAN)为代表的单光子发射计算机断层成像示踪剂已获FDA批准，用于评估黑质纹状体通路的完整性，可在出现运动症状前3~5年检测到DAT密度降低，用于鉴别PD与特发性震颤、帕金森综合征[39]。以[123I]FP-CIT为先导化合物经18F标记获得的[18F]FP-CIT以及由[11C]PE2I衍生而来的[18F]FE-PE2I均可用于PD的早期诊断[40-41]。[18F]FP-CIT已被证明是评估PD患者DAT密度的有效工具，但缺点是在反映PD患者运动及认知症状严重程度方面存在一定局限[42]。相比之下，[18F]FE-PE2I对DAT具有更高的选择性和亲和力，且对5-羟色胺转运体的亲和力低，因此在PET成像中展现出更优的靶与非靶比和更好的图像对比度。Delva等[43]利用[18F]FE-PE2I-PET成像，对壳核尾部至嘴部的DAT密度进行精准量化，实现了对PD进展的客观评估。Kerstens等[44]在一项验证性研究中发现，PD患者中DAT密度与国际帕金森与运动障碍学会统一帕金森病评定量表(MDS‑UPDRS)-III评分呈显著负相关(r=－0.47，P<0.05)。这一特性使得[18F]FE-PE2I可作为临床试验的替代终点，用于评估疾病修饰疗法与神经保护治疗策略对多巴胺能系统的影响。
多巴胺合成与代谢示踪剂可直接靶向多巴胺能神经元的胞内生化过程，为评估其功能活性提供分子水平证据。以[18F]FDOPA为代表的PET示踪剂可反映纹状体多巴胺能神经末梢对左旋多巴类似物的摄取、脱羧及储存能力，已在欧洲和美国上市[45]，用于帕金森综合征相关的多巴胺能神经元功能评估。与主要反映DAT完整性的[123I]ioflupane不同，[18F]FDOPA可从多巴胺合成与储存功能层面揭示黑质-纹状体通路的受损状态。因此，[18F]FDOPA PET与[123I]ioflupane显像可从不同环节互补评估多巴胺能系统功能，为PD及相关帕金森综合征的病情评估和鉴别诊断提供影像学依据。目前，[18F]FDOPA在中国已进入III期临床试验阶段，未来若获批上市，可进一步丰富PD及相关帕金森综合征的分子影像评价体系[46]。
多巴胺D2/D3受体主要分布于纹状体等脑区的突触后膜，是调控运动、情感和精神活动的关键靶点。以[11C]RAC为代表的苯甲酰胺类D2/D3受体PET显像剂，凭借高受体选择性(Ki=1.2 nmol/L)及适中的动力学特性，已成为科研和临床中评估纹状体受体功能的“金标准”[47]。而[11C]FLB457则因其极高的亲和力，能够实现对纹状体外低密度受体的有效显像。尽管二者结合可为全脑多巴胺能系统的多层次评估提供有力工具，但是11C核素较短的半衰期限制其广泛应用[48]。在此背景下，[18F]Fallypride作为新一代高亲和力苯甲酰胺类D2/D3受体探针展现出独特优势：它不仅能够清晰显示纹状体等高密度区域的受体分布，还可有效探测大脑皮质等低密度区域，从而实现对全脑D2/D3受体的全面可视化。Huhtala等[49]进一步优化了[18F]Fallypride的合成方法，实现高产率、高摩尔活度制备，并使用该方法检测到亨廷顿病患者脑内D2/D3受体密度显著下降，确定了[18F]Fallypride作为定量评估工具的临床价值。此外，该探针有高对比度成像特性，能够对精神分裂症患者D2受体功能受损进行可视化评估，为临床病理机制研究与药物疗效评估提供新的窗口与研究路径[50]。
囊泡单胺转运体(VMAT2)显像剂可直接定量评估脑中多巴胺能神经末梢的完整性，是诊断PD等突触核蛋白病最可靠的生物标志物，其密度直接反映了存活的多巴胺能神经元数量。在二氢丁苯那嗪衍生物这类显像剂中，[11C]DTBZ最为经典，其18F标记的类似物[18F]FP-DTBZ具有更适宜的半衰期，目前已被广泛应用于临床研究[51]。多巴胺D2/D3受体的[18F]Fallypride与靶向VMAT2的[18F]FP-DTBZ联用，为突触前多巴胺能终端功能评估提供了多维度、特异性的手段，有助于更全面评估PD进展。另外，Zhao等[52]采用固相合成法实现了D6-[18F]FP-DTBZ的自动化合成，首次在人体中评估了其安全性、生物分布与辐射剂量学特征。该研究在健康受试者中将D6-[18F]FP-DTBZ与[18F]FP-(+)-DTBZ进行头对头比较，结果显示氘代后的DTBZ核素探针(D6-[18F]FP-DTBZ)在VMAT2高密度区域(尾状核、壳核和伏隔核)中摄取量明显高于未氘代的DTBZ核素探针([18F]FP-(+)-DTBZ)，总体摄取量的标准摄取值比值高出约15%[52]；同时，在PD患者中行D6-[18F]FP-DTBZ显像发现，随着PD患者纹状体中VMAT2减少，摄取量显著降低，尤其是在壳核部位，体现出其诊断PD的潜力[52]。
5. α-syn靶向示踪剂：α-syn在PD患者脑内的异常聚集，始于其前体原纤维暴露的含特异性负电荷簇的C端疏水腔(尺寸8~12 Å)，该结构促进了α-syn病理性聚集的起始与扩展，最终在神经元胞体与突起中分别形成路易小体(Lewy body，LB)或路易突起(LN)[53]。值得注意的是，α-syn的病理性聚集同样见于路易体痴呆(DLB)和MSA等疾病中[54]。α-syn聚集时会形成与Aβ和tau蛋白类似的β-折叠结构，部分tau蛋白显像剂(如[18F]BF227、[11C]PBB3和[18F]Florzolotau)曾被尝试用于α-syn显像，但因其选择性不足而应用受限。
近年来，随着分子结构的持续优化，一批更具前景的α-syn特异性显像剂不断涌现。研究表明，吡唑并吡咯烷酮衍生物[18F]ACI-12589通过非平面螺旋构象、叔胺基团在生理pH下质子化以及易于形成氢键等优势，对α-syn聚集体表现出高选择性。放射自显影结果显示：[18F]ACI-12589在PD患者中的信号强度与健康受试者相比高出2~3倍，在MSA患者中的信号强度高出30倍，可明显区分MSA患者与健康受试者，为帕金森综合征疾病分类提供了强有力的潜在工具[55]。此外，Goto等[56]设计合成苯并咪唑吡啶酮衍生物[18F]SPAL-T-06和[18F]C05-05，系统评估了其在健康人体内全身生物分布、安全性和辐射剂量学，结果显示这两种探针在脑内均呈现较低的背景摄取；其中，[18F]SPAL-T-06可在MSA患者中实现对α-syn沉积部位的高对比度成像，而[18F]C05-05也被证实能有效检测PD和DLB患者脑内的α-syn沉积。
6. 突触密度靶向PET示踪剂：突触丢失是AD和PD共同的关键病理生理特征，且突触损耗往往早于神经元凋亡及明显的脑萎缩，是导致认知障碍和运动功能减退的最直接原因。位于突触囊泡膜上的SV2A作为反映活体突触密度的核心生物标志物，已成为评估AD和PD病情进展的新靶点。研究者们开发了一系列新型靶向SV2A的PET放射性示踪剂，包括[11C]UCB-J[57]、[18F]UCB-J[58]、[18F]UCB-H、[18F]SDM8[59]和[18F]SynVesT-2[60]等。
18F标记的[18F]UCB-J探针的药代动力学和成像特性与[11C]UCB-J相似，代谢率适中，脑摄取率高，特异性结合度强，图像质量进一步提高，有助于人体内SV2A表达和突触密度的成像与定量分析[58]。[18F]UCB-H是较早开发的SV2A示踪剂之一，在AD小鼠模型和非人灵长类动物研究中表现出较高的脑摄取，与SV2A脑内分布相匹配，但特异性低，限制了其在NDDs中的应用[61]。与[11C]UCB-J相比，[18F]SDM8在非人灵长类动物和人脑部表现出良好的成像特性，脑部摄取量高、适宜的动力学特征及特异性结合，显示出靶向SV2A的潜力，有望成为SV2A的优良放射性示踪剂[61]。[18F]SynVesT-2在非人灵长类及首次人体研究中均显示出快速动力学特性：注射后约10 min脑内放射性达峰，特异性高、非特异性摄取量低，对MCI和AD患者认知功能评估具有重要意义，目前其临床转化正在推进中[61]。
7. TSPO靶向PET示踪剂：TSPO主要在活化的小胶质细胞中显著上调，是中枢神经系统免疫反应的核心生物标志物。通过PET对TSPO进行定量检测，能够实时追踪神经炎症活动，为揭示NDDs中的神经炎症与其他病理改变间的关联机制提供关键信息。尽管[11C]PK11195作为首个TSPO靶向PET示踪剂具有开创意义，但由于脑内渗透率低、非特异性结合高及血浆蛋白结合率高等问题，其临床应用受限[62]。
为克服第一代示踪剂的局限，多种新型配体已被开发并在AD和PD中开展评估。Yang等[63]首次在人体内评估了苯并二氮卓类衍生物[18F]GE180，并通过与Aβ显像剂[18F]Florbetapir进行对比，发现其脑内摄取虽与AD病理负荷相关，但因亲和力有限，其临床转化面临挑战。[18F]DPA-714是一种吡唑并嘧啶乙酰胺类TSPO示踪剂，具有较高的亲和力和特异性，已用于多种神经炎症研究。López-Picón等[64]在AD小鼠模型中发现[18F]DPA-714展现出更快的清除速率，使其具有较[11C]PBR28更清晰的脑内摄取。这也揭示了开发理想神经炎症显像剂时所面临的核心挑战，即靶向性、特异性与清除率三者之间的平衡。Ye等[65]的研究也拓展了[18F]DPA-714在PD领域的早期诊断价值：在经6‑羟基多巴胺诱导1周的PD大鼠模型中，[18F]DPA-714 PET-MRI成像提示TSPO信号显著上升，且该强度与运动缺损程度呈正相关(r=0.434，P<0.05)，表明[18F]DPA-714能灵敏地检测由早期小胶质细胞激活引发的神经炎症，为PD的病理进程监测提供了新视角。
二、总结与展望
近年来，围绕Aβ、tau蛋白、α-syn、多巴胺能系统、SV2A和TSPO等靶点开发的PET示踪剂，已逐步实现对特定病理过程无创、定量和可视化评估，为NDDs的早期识别、鉴别诊断、病理分型及疗效监测提供了重要的分子影像依据。然而，单一靶点显像往往难以全面反映疾病全貌，未来PET分子影像的发展方向应从单靶点检测逐步转向多靶点、多维度的综合评估：(1)在AD中，基于Aβ、tau蛋白和FDG联合的“A/T/N”显像有助于同时评估多种病理改变与疾病进展风险，并提高对MCI向AD转化的风险分层能力。(2)在PD中，DAT、VMAT2及多巴胺D2/D3受体等靶点的综合评价，从而有利于实现从突触前神经元完整性、囊泡储存能力到突触后受体状态等不同层面反映黑质－纹状体多巴胺能通路功能变化，有望实现鉴别诊断及病理分型。(3)随着中国放射性药品注册监管体系和临床转化环境的不断完善，以[18F]Florbetazine和[18F]Florzolotau为代表的国内原研或中国主导临床转化的PET探针的临床应用正在推进，为NDDs的早期筛查和精准诊断提供了新的工具。
展望未来，随着人工智能、多组学和系统生物学等技术的交叉融合，靶向既有靶点和新发现靶点的示踪剂将得到持续开发，分子影像技术和定量分析方法进一步发展，从而实现对NDDs病理异质性和疾病进程的可视化。其价值不仅体现在早期诊断和鉴别诊断中，也将延伸至患者分层、疗效监测、疾病进展预测、新药研发和伴随诊断等方面。通过推动“机制探索→靶点发现→探针设计→开发筛选→临床验证→精准诊疗”的转化链条，PET分子影像将为AD和PD等NDDs的个体化管理提供更加可靠的技术支撑。
参考文献略
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排版：周穗莉
校对：凌桂芳
审核：王志娟
放射疗法上市批准诊断试剂
2026-06-29
《从实验室到市场的转化 —— 分子显像剂的开发》内容简介、总结与展望一、文章简介：
本文为朱霖、孔繁渊（Hank F Kung）于2014年撰写的转化医学综述（DOI：10.3868/j.issn.2095-154X.2014.01.002）。
文章以转化医学为核心视角，通过Hank F Kung (孔繁渊) 团队国际首创的两个具体核药案例——99mTc-TRODAT-1（多巴胺转运体显像剂-帕金森病SPECT显像剂）和18F-AV-45（Florbetapir/Amyvid，β-淀粉样蛋白PET显像剂-阿尔茨海默症显像剂），系统展示了分子显像剂从基础研究到FDA批准上市的完整历程，揭示了其中面临的科学、商业和监管多重挑战。
核心观点：一个成功的分子影像产品不仅需要科学创新，还需要专利、资本、临床验证、监管审批和商业推广的共同支持。关键教训：
科学成功 ≠ 商业成功：TRODAT-1临床实用性良好，但因商业因素未能充分开发
专利布局决定市场边界：早期专利申请的地域范围直接影响后期市场空间
资金连续性至关重要：公司重组、金融危机等外部因素可能中断转化进程
政策窗口需要把握：FDA的eIND政策为AV-45的临床试验提供了关键便利
这篇文章是理解转化医学"死亡之谷"——即从基础研究到临床应用之间鸿沟——的经典案例研究，对当前中国创新药研发仍具有重要参考价值。转化政策背景
美国 1981 年《拜杜法案》推动高校科研成果产业化，赋予非营利学术机构政府资助成果的专利权与技术转让权，但落地过程存在多重现实阻碍：高校缺乏商业化运营能力、专利授权流程复杂、企业合作存在商业陷阱、初创药企融资困难、学术使命与商业利益冲突、科研人员面临学术道德与利益平衡难题。放射性显像剂基础分类
区分 SPECT 与 PET 两类显像技术对应的常用核素：
SPECT：Tc-99m（半衰期 6h，易得、成本低），I-123加速器生产，成本高；
PET： C-11半衰期仅 20min，仅大型中心可使用；F-18半衰期 110min，便于集中生产配送，是临床主流，代表药物18F -FDG。
放射性显像剂给药剂量为微克级，毒性风险低，质控核心为放射性纯度，相比传统治疗药物具备独特转化优势。案例 1：帕金森病 SPECT 显像剂99mTc-TRODAT-1
靶向多巴胺转运体（DAT），1996 年完成人脑成像验证，临床效果与欧美上市123I-DaTscan相当，且成本更低、获取便捷。
转化历程：宾大Upenn申请Trodat-1专利并授权日本 Medi-Physics，后续企业多次重组，GE 最终放弃其欧美开发，主推I-123 DaTscan；因Trodat-1早期专利未覆盖中国台湾、巴西、印度等地区，台湾地区完成三期临床并于 2006 年获批上市。
案例揭示：显像剂临床有效性不能决定商业化成败，专利布局、药企战略、市场定位会直接决定产品落地范围。案例 2：阿尔茨海默病 PET 显像剂 18F-AV-45（Florbetapir，Amyvid）
靶向脑内 β 淀粉样斑块，用于阿尔茨海默病（AD）病理诊断。
转化历程：宾大Upenn作为专利权人授权AVID 放射性药物公司（由专利发明人Hank F Kung教授作为创始人之一创立）进行孵化，历经多轮风险融资，金融危机下仍完成临床开发；依托 FDA 探索性 eIND 政策简化毒性试验流程，一至三期临床证实其可清晰区分健康人与 AD 患者脑内淀粉样斑块负荷；2012 年成为全球首款 FDA 获批的 Aβ 斑块 PET 显像剂, 2010年底AVID公司被 Eli Lilly and Company（礼来公司） 收购。后续多款F-18标记 Aβ 显像剂陆续获批，包括AVID公司转给德国先灵公司（后被德国贝尔公司并购）的AV-1（2014年上市），均可用于 AD 早期筛查、抗淀粉样药物受试者筛选。二、全文总结：技术层面
短寿命核素分子显像剂在神经退行性疾病（帕金森、阿尔茨海默病）诊断价值突出，Tc-99m适配普及型 SPECT，F-18适配规模化 PET，两类探针可实现脑内病变靶点可视化；但不同核素物理特性直接限制生产、配送与临床推广范围。转化成败核心规律
显像剂临床疗效只是转化成功的基础，专利布局、药企并购战略、融资环境、监管政策、市场规模、医保商业化配套是决定成果能否落地的关键约束条件：
失败案例 99mTc-TRODAT-1：产品性能优异，但欧美药企战略放弃、专利地域覆盖不全，仅小众市场实现商业化；
成功案例 18F-AV-45：依托高校专利授权、自建生物公司、抓住 FDA 政策红利、持续获得风投支持，完整走完临床与新药注册流程，实现全球商业化。现有转化体系的固有矛盾
《拜杜法案》打通了政府资助科研成果商业化的法律通道，但高校无产业运营能力、学术科研与商业开发目标冲突、中小型核药企业融资难度大、新药注册周期长、研发成本高昂（PET/SPECT 显像剂注册成本约 5000 万美元），大幅抬高实验室成果落地门槛。临床应用价值
获批分子显像剂可实现神经退行性疾病病理层面早期诊断，区别于传统症状诊断，为疾病早期干预、新药临床试验受试者筛选提供客观影像学依据。三、行业展望：
技术研发方向：持续开发新型F-18标记 PET、Tc-99m标记 SPECT 脑靶向探针，拓展 tau 蛋白、五羟色胺转运体、VMAT2 等更多神经靶点显像剂；优化放射性标记化学工艺，降低生产成本、简化生产流程，进一步提升基层医院可及性。
科研转化机制优化：高校需搭建专业化技术转移平台，完善专利全球布局规划，避免因专利地域缺失丢失市场；高校、医院、初创核药企业、大型药企建立协同转化模式，分担高额临床注册与研发成本，缓解风投波动带来的资金断裂风险。
监管与产业配套完善：参考 FDA eIND 简化临床试验的政策思路，各国监管机构推出适配放射性药物的特殊审批通道；完善核药房集中配送体系，解决短寿命核素储运难题；推动放射性诊断显像剂纳入医保报销，打开长期市场空间。
临床应用拓展：以 Aβ、DAT 显像剂为模板，将分子显像技术推广至神经退行性疾病早期筛查、病程动态监测；赋能抗阿尔茨海默、抗帕金森新药研发，成为新药临床试验核心影像学评价工具；同时推动低成本Tc-99m类显像剂在新兴医疗市场普及，弥补高价PET 药物覆盖不足的短板。
产学研协同发展：依托顶尖放射性药物实验室（高校、研究院所等）持续输出源头创新，通过校企联合创业、药企授权开发双路径并行，平衡学术创新与商业落地，让更多靶向分子显像剂从实验室走向临床，惠及广大疾病患者。
2026-06-01
Nuclear medicine is reaching an inflection point as advances in imaging, theranostics and radiopharmaceuticals help accelerate clinical adoption
At #SNMMI26, GE HealthCare is showcasing solutions designed to expand access, streamline workflows and support precision care across care pathways
CHICAGO--(BUSINESS WIRE)--As theranostics adoption acceleratesi and radiopharmaceutical demand grows,ii healthcare systems are under increasing pressure to scale nuclear medicine operations while improving diagnostic confidence and workflow efficiency. At the 2026 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, GE HealthCare showcases its latest technologies and AI-enabled workflows to help support precision care across care pathways.
“This is an exciting moment for nuclear medicine because we are moving beyond simply detecting disease to truly understanding its biology and behavior,” says Dr. Munir Ghesani, MD.
Nuclear medicine is undergoing rapid expansion as healthcare systems increase adoption of theranostics, broaden radiopharmaceutical access and invest in precision diagnostics and targeted therapies. This momentum is also evident in global nuclear medicine market projections, which anticipate growth from approximately $7.8 billion in 2024 to more than $30.7 billion by 2034.iii
“Nuclear medicine is moving from early innovation to large-scale clinical implementation,” shares Jean-Luc Procaccini, President and CEO, Molecular Imaging and Computed Tomography (MICT), GE HealthCare. “Healthcare systems need technologies and workflows that help expand access, improve efficiency and support more confident clinical decision-making as theranostics adoption and precision care evolve.”
Turning convergence into clinical reality
Growing demand for precision diagnostics and targeted therapies is helping accelerate the evolution of nuclear medicine. Advances in radiopharmaceuticals and imaging technologies help clinicians diagnose disease, improve treatment planning and expand access to personalized care. As adoption increases, healthcare systems are also facing new operational challenges – including how to scale infrastructure, streamline workflows and expand patient access beyond traditional hospital settings.iv
Rising prevalence of chronic diseases is further driving demand for timely and advanced diagnoses and targeted treatment approaches. Fortunately, new care delivery models are already taking shape across care pathways. These models are increasingly enabled by advances in radiopharmaceuticals that expand access to PET imaging and support more scalable, routine clinical use across care settings.
Early examples of this shift are emerging to reach patients beyond traditional hospital environments:
Cardiology : GE HealthCare’s Flyrcado™ (flurpiridaz F 18 injection) is helping expand access to PET myocardial perfusion imaging (MPI) through a ready-to-use, unit-dose model designed for routine clinical workflows. The company is also collaborating with channel partners to accelerate the adoption of cardiac PET MPI in community settings while mobile imaging models are extending access beyond traditional hospital environments, bringing precision PET imaging to sites that may not otherwise have access.
Neurology : As demand for Alzheimer’s diagnostics grows, v GE HealthCare offers Vizamyl™ (flutemetamol F 18 injection) and quantitative tools such as MIMneuro™ to support more consistent amyloid PET interpretation and clinical decision-making. These technologies can help providers integrate amyloid imaging more efficiently into routine neurological care pathways.
Oncology : Theranostics adoption is also accelerating, i causing healthcare systems to seek more standardized approaches to imaging, treatment planning and response assessment. GE HealthCare’s StarGuide SPECT/CT, Intelligent Radiation Therapy (iRT) and MIM portfolio are designed with these needs in mind – helping simplify whole-body tumor burden assessment, streamline workflows and support more consistent treatment planning across care settings. These capabilities also support GE HealthCare’s vision for Adaptive Theranostics™ – a connected, data-driven approach that integrates molecular imaging, quantitative analysis and multidisciplinary workflows to help tailor therapy decisions over time.
These capabilities also support GE HealthCare’s vision for Adaptive Theranostics™ – a connected, data-driven approach that integrates molecular imaging, quantitative analysis and multidisciplinary workflows to help tailor therapy decisions over time.
“This is an exciting moment for nuclear medicine because we are moving beyond simply detecting disease to truly understanding its biology and behavior,” says Dr. Munir Ghesani, MD, FACNM, FACR, FSNMMI, Chief Medical Officer at United Theranostics and System Chief of Nuclear Medicine at the Mount Sinai Health System in New York. “Technologies that combine advanced imaging, quantitative analysis and innovative radiopharmaceuticals are helping clinicians make more informed decisions earlier in the care pathway – ultimately improving how we diagnose, treat and monitor patients.”
GE HealthCare’s nuclear medicine portfolio spans imaging systems, AI-enabled software and pharmaceutical diagnostics designed to help clinicians support the full patient journey — from detection and diagnosis through therapy planning and monitoring.
Translating rapid innovation into real-world clinical impact
At SNMMI 2026, GE HealthCare is highlighting key technologies and software designed to help healthcare systems scale precision imaging, theranostics and quantitative analysis across clinical and research settings:
Advanced imaging technologies –
MIM KineticID ™: vi Advanced 510(k)-pending software designed for dynamic PET imaging and kinetic modeling, enabling quantitative, time-based analysis of radiotracer behavior to support more informed clinical and research decisions.
MIM LesionID™ Pro : Recently 510(k) cleared by the U.S. FDA , this AI-powered software automates whole-body tumor burden analysis, reducing the need for manual lesion segmentation, physiologic uptake removal, or multi-image registration while enabling fast access to quantitative insights.
Omni Legend : GE HealthCare’s fastest-selling PET/CT platform, now with more than 500 installations worldwide. vii Its high-sensitivity design supports faster scans, viii improved image quality and enhanced lesion detectability. ix Omni Legend also includes Precision DL deep learning image processing.
StarGuide : A digital SPECT/CT platform featuring 12 CZT detectors and optimized for certain theranostic procedures, enabling high-quality 3D imaging, short scan times and quantitation.
MINItrace Magni : x A compact cyclotron solution designed to simplify onsite production of PET tracers and radiometals, including Gallium-68, helping expand radiopharmaceutical access and support more localized production and personalized care delivery.
Radiopharmaceuticals and imaging agents –
Flyrcado : A PET imaging agent that helps doctors evaluate myocardial ischemia and infarction in people with known or suspected coronary artery disease, including during exercise stress tests.
DaTscan ™ (ioflupane I‑123 injection): A proven neurological diagnostic radiopharmaceutical – celebrating 25 years in the global market – to visualize striatal dopamine transporters assisting in the evaluation of patients with suspected Parkinsonian syndromes (PSs) and suspected dementia with Lewy bodies (DLB).
Cerianna ™ (fluoroestradiol F 18 injection): A PET radiopharmaceutical used to detect estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
Vizamyl : A PET imaging agent used to estimate amyloid beta neuritic plaque density in adults with cognitive impairment to support evaluation of Alzheimer’s disease and other causes of cognitive decline, and to help inform selection of patients for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.
Together, these imaging technologies and agents are designed to support more scalable, data-driven and personalized nuclear medicine workflows across care pathways.
Preparing the ecosystem for the next decade of growth
As nuclear medicine adoption continues to grow, healthcare systems are increasingly focused on the operational requirements needed to support broader clinical use – including infrastructure, workflow standardization, radiopharmaceutical access and scalable decision support. xi
Quantification and advanced imaging analytics are expected to play an increasingly important role in this evolution, particularly in neurodegenerative disease and theranostics, where more standardized interpretation and longitudinal assessment may help advance consistency across sites and clinicians.
One way GE HealthCare is aiming to advance this evolution is through Adaptive Theranostics – a model that combines molecular imaging, quantitative analytics and connected clinical workflows to help clinicians personalize radioligand therapy decisions across treatment cycles. By supporting more consistent quantification, longitudinal assessment and multidisciplinary collaboration, Adaptive Theranostics is designed to help healthcare systems scale precision care as theranostics adoption grows.
“As molecular imaging continues to scale, success will depend on more than individual products – it requires building the ecosystem around them,” says Eric Ruedinger, Vice President and General Manager, Pharmaceutical Diagnostics (PDx), USCAN, GE HealthCare. “We’re focused on enabling that ecosystem end-to-end – from tracer development and manufacturing to expanding access, integrating workflows and advancing the tools that support confident, consistent decision-making – so precision care can move from promise to sustained, everyday practice.”
SNMMI 2026 represents a pivotal moment for the field – where decades of innovation are converging with new care models and expanding access to redefine how nuclear medicine is delivered.
As these capabilities continue to scale, nuclear medicine is increasingly positioned as a cornerstone of precision medicine – enabling clinicians to visualize the biology of disease, tailor therapies to individual patients and monitor treatment response.
To learn more about GE HealthCare’s full suite of nuclear medicine solutions, please visit gehealthcare.com.
About GE HealthCare Technologies Inc.
GE HealthCare is a leading global healthcare solutions provider of advanced medical technology, pharmaceutical diagnostics, and AI, cloud and software solutions that help clinicians tackle the world’s most complex diseases. Serving patients and providers for 130 years, GE HealthCare is delivering bold innovations designed for the next era of medicine across its Advanced Imaging Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics segments to help clinicians deliver more personalized, precise patient care. We are a $20.6 billion business with approximately 54,000 colleagues working to create a world where healthcare has no limits.
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Important Safety Information
Cerianna™ (fluoroestradiol F 18 injection)
Indication and Usage:
Cerianna is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
Limitations of Use:
Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. Cerianna is not useful for imaging other receptors such as HER2 or progesterone receptor (PR).
Contraindications:
None.
Adverse Reactions:
In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 800-FDA-1088 or www.fda.gov/medwatch.
For full prescribing information, please visit:
https://www.gehealthcare.com/-/jssmedia/GEHC/US/Files/Products/Nuclear-Imaging-Agents/Cerianna/cerianna-pi
DaTscan™ (ioflupane I‑123 injection)
Indication and Usage:
DaTscan is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB).
Contraindications:
Known hypersensitivity to ioflupane I‑123 or its components.
Adverse Reactions:
In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness were reported at a rate of 1% or less. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported.
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.
Prior to DaTscan administration, please read the full Prescribing Information for additional Important Safety Information.
Flyrcado™ (flurpiridaz F 18 injection)
Indication and Usage:
Flyrcado is a radioactive diagnostic drug indicated for PET myocardial perfusion imaging (MPI) under rest or stress in adult patients with known or suspected coronary artery disease (CAD) to evaluate myocardial ischemia and infarction. [accessdata.fda.gov]
Contraindications:
None.
Adverse Reactions:
The most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 800-FDA-1088 or www.fda.gov/medwatch.
For full prescribing information, click here. For important safety information, please click here.
Vizamyl™ (flutemetamol F 18 injection)
Indication and Usage:
VIZAMYL™ (flutemetamol F 18 injection) is indicated for positron-emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline; and selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products
Contraindications:
Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80.
Adverse Reactions:
The most commonly reported adverse reactions in clinical trials were flushing (2%), increased blood pressure (2%), headache (1%), nausea and dizziness (1%). Post marketing experience included anaphylactic reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 800-FDA-1088 or www.fda.gov/medwatch.
For full prescribing information, please visit:
https://www.gehealthcare.com/content/dam/gehc/global/products/molecular-imaging-agents/vizamyl/documents/er-clinical-product-pi-en.pdf
May 2026 JB14025US
i Ezhilarasan, E., Sabarees, G. & Premkumar, P.P. Radioligand theranostics in oncology: emerging trends in target design and radiochemical innovation. J Radioanal Nucl Chem (2026). https://link.springer.com/article/10.1007/s10967-026-10891-3.
ii Research and Markets. Radiopharmaceuticals Market Report 2026. Dublin: Research and Markets, 2026. https://www.researchandmarkets.com/reports/5939063/radiopharmaceuticals-market-report.
iii Global Market Insights. U.S. Nuclear Medicine Market Size & Share, 2025–2034. Published October 2025. Accessed May 4, 2026. https://www.gminsights.com/industry-analysis/us-nuclear-medicine-market.
iv Global Market Insights. Nuclear Medicine Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2025–2034. Published October 8, 2025. Accessed April 16, 2026. https://www.giiresearch.com/report/gmi1858986-nuclear-medicine-market-opportunity-growth-drivers.html?utm_source=chatgpt.com
v Grand View Research. U.S. Alzheimer’s Disease Diagnostics Market Report, 2030. San Francisco: Grand View Research, 2025. https://www.grandviewresearch.com/industry-analysis/us-alzheimers-disease-diagnostics-market-report.
vi MIM KineticID is 510(k)-pending with the U.S. FDA. Not CE Marked. Not available for sale in the United States, Europe, Canada, or any other region.
vii GE HealthCare data on file.
viii Up to 53% reduction of PET scan time on Omni Legend 32 cm compared to Discovery MI 25 cm, as demonstrated in phantom testing.
ix Omni Legend 32 cm increases small lesion detectability 16% on average and up to 20%, as compared to Discovery MI 25 cm with matched scan time/injected dose, as demonstrated in phantom testing using a model observer with 4 mm lesions; average of different reconstruction methods.
x MINItrace Magni is technology in development. Not CE marked.
xi Global Market Insights. Nuclear Medicine Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2025–2034. Published October 8, 2025. Accessed April 16, 2026. https://www.giiresearch.com/report/gmi1858986-nuclear-medicine-market-opportunity-growth-drivers.html?utm_source=chatgpt.com
100 项与 碘[123I]氟潘 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 路易体病 | 美国 | 2022-11-01 | |
| 诊断试剂 | 日本 | 2013-09-20 | |
| 特发性震颤 | 韩国 | 2011-04-15 | |
| 帕金森病 | 韩国 | 2011-04-15 | |
| 帕金森障碍 | 欧盟 | 2000-07-27 | |
| 帕金森障碍 | 冰岛 | 2000-07-27 | |
| 帕金森障碍 | 列支敦士登 | 2000-07-27 | |
| 帕金森障碍 | 挪威 | 2000-07-27 | |
| 帕金森障碍 | 英国 | 2000-07-27 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 帕金森病所致痴呆 | 临床3期 | 中国 | 2020-06-28 | |
| 帕金森病所致痴呆 | 临床3期 | 中国 | 2020-06-28 | |
| 帕金森病所致痴呆 | 临床3期 | 中国 | 2020-06-28 | |
| 多系统萎缩 | 临床3期 | 中国 | 2020-06-28 | |
| 多系统萎缩 | 临床3期 | 中国 | 2020-06-28 | |
| 多系统萎缩 | 临床3期 | 中国 | 2020-06-28 | |
| 多系统萎缩 | 临床3期 | 中国 | 2020-06-28 | |
| 原发性帕金森病 | 临床3期 | 中国 | 2020-06-28 | |
| 原发性帕金森病 | 临床3期 | 中国 | 2020-06-28 | |
| 原发性帕金森病 | 临床3期 | 中国 | 2020-06-28 |
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临床结果
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适应症
分期
评价
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | 172 | (DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)) | 鑰範網鹽鏇製願構醖鬱 = 築鬱鑰餘廠獵襯願憲範 鬱鏇壓蓋鏇繭膚顧網繭 (構壓淵鹽壓願鏇夢鏇顧, 廠顧膚衊遞蓋鏇簾壓簾 ~ 廠夢選夢願簾餘構製製) 更多 | - | 2023-10-16 | ||
(DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)) | 願膚餘願艱壓淵構衊簾 = 廠齋齋衊艱觸糧憲憲築 遞壓選觸網積範艱衊構 (廠艱築選餘鏇鹽艱蓋鬱, 簾鹽夢製鏇構鬱鹹淵蓋 ~ 壓選願構衊願簾網鹽壓) 更多 | ||||||
临床1期 | - | 9 | 憲製蓋築製蓋鹽顧鹽齋 = 餘餘鑰觸鹽繭範積醖鹽 膚繭鏇壓築遞製糧觸鏇 (淵鏇鏇膚築衊醖範選網, 鏇壓鹹構簾製窪獵鹹鏇 ~ 艱簾鹽獵憲願壓鬱窪積) 更多 | - | 2023-08-02 | ||
N/A | 34 | 繭顧願窪獵淵糧窪鬱壓(醖夢積夢廠選廠觸艱繭) = 夢鹽餘獵餘廠襯夢膚繭 膚憲憲醖鹹醖積願壓憲 (糧鏇醖獵憲製齋衊壓鹽 ) 更多 | - | 2022-05-03 | |||
繭顧願窪獵淵糧窪鬱壓(醖夢積夢廠選廠觸艱繭) = 鹹繭鏇窪構夢鬱蓋襯餘 膚憲憲醖鹹醖積願壓憲 (糧鏇醖獵憲製齋衊壓鹽 ) 更多 | |||||||
临床2期 | 帕金森病 [123I]FP-CIT SPECT | 390 | (PD patients with gait impairment) | 構觸壓顧壓鑰鬱選積襯(窪簾醖醖願廠築窪鑰衊) = 構鬱鑰願範簾鹽獵網繭 遞糧醖簾憲夢鏇蓋鹹衊 (積餘繭夢鬱鬱顧鹹憲鏇 ) | 积极 | 2019-06-27 | |
临床2期 | 帕金森病 [123I]FP-CIT SPECT | MDS-UPDRS | 389 | (PD patients with drooling) | 鏇觸壓醖築簾鬱艱襯獵(蓋廠網獵壓襯襯艱顧壓): HR = 1.823 (95% CI, 1.176 ~ 2.827), P-Value = 0.007 | 积极 | 2019-06-27 | |
(PD patients without drooling) | |||||||
临床2期 | 帕金森病 dopamine transporter (DAT) | 167 | 123-I Ioflupane SPECT | 選壓鏇觸鹽衊壓襯廠餘(襯廠鹽鏇觸餘鏇範蓋糧) = 壓遞衊鹹簾構簾鑰艱製 遞糧製蓋淵廠壓餘願餘 (獵築鹽鹹積鬱簾壓積壓 ) | 积极 | 2015-04-06 | |
临床2期 | 帕金森病 dopamine transporter SPECT imaging | 298 | 123-I Ioflupane SPECT | 餘衊鹽繭鏇糧遞鬱製鏇(醖願製憲襯網築襯鏇範) = 範鏇鹽積鑰膚衊醖蓋鑰 範餘積遞觸網顧選襯壓 (艱獵顧遞窪襯鹽鑰觸網, 15.6%) | 积极 | 2014-11-05 | |
(PD subjects with 3 SPECT scans) | 餘衊鹽繭鏇糧遞鬱製鏇(醖願製憲襯網築襯鏇範) = 廠艱顧鏇願繭築範醖繭 範餘積遞觸網顧選襯壓 (艱獵顧遞窪襯鹽鑰觸網, 15.6%) | ||||||
N/A | 路易体病 123I-FP-CIT SPECT | 325 | 蓋積觸構衊遞築醖襯艱(簾鹽鹽製築鑰願積獵鏇) = 夢廠襯願簾鑰鏇鏇醖廠 糧醖鹽築鑰繭鏇蓋築遞 (廠鏇壓壓簾窪築鏇衊淵 ) 更多 | 积极 | 2008-07-01 |
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