The purpose of the study is to investigate the use of a special radioactive drug called 123I-MIBG and myocardial MIBG scintigraphy. This scan may be able to help determine who may have a certain kind of neurologic disorder called Lewy Body Disease.
The overall purpose of this study is to correlate myocardial MIBG scintigraphy findings with clinical diagnosis. Myocardial MIBG scintigraphy imaging will be combined with other clinical, neuropsychological and neuroimaging findings to improve the prediction for underlying Lewy Body Disease.

开始日期2023-05-08

申办/合作机构

Mayo Clinic

NCT04614766

/ Withdrawn临床1/2期IIT

A Phase 1/2 Trial Using AZEDRA and LUTATHERA in a Dosimetrically-determined Optimal Combination for Therapy of Selected Patients With Midgut Neuroendocrine Tumors

This study is designed to identify the best tolerated doses of Lutathera® and Azedra® when co-administered to treat midgut neuroendocrine tumors. These drugs are radioactive drugs, known as radionuclide therapy, and are both approved in the treatment of midgut neuroendocrine tumor as single agents (not together). Currently, the safest and best tolerated doses of these drugs (when combined) is unknown. That is the purpose of this clinical trial.

开始日期2022-09-30

申办/合作机构

University of Iowa

[+3]

JPRN-jRCTs041190085

/ Completed临床2期IIT

Targeted radiotherapy for malignant neuroendocrine tumors with I-131 metaiodobenzylguanidine (MIBG) (Targeted radiotherapy for malignant neuroendocrine tumors with I-131 metaiodobenzylguanidine (MIBG)) -phase2 trial-

开始日期2019-11-27

申办/合作机构-

100 项与碘[131I]苄胍相关的临床结果

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100 项与碘[131I]苄胍相关的转化医学

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100 项与碘[131I]苄胍相关的专利（医药）

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项与碘[131I]苄胍相关的文献（医药）

2025-04-01·ESMO Open

131I-mIBG therapy in relapsed/refractory neuroblastoma: an old bridge to the future

Article

作者: Del Bufalo, F ; Davide, C ; Garganese, M C ; Tomà, P ; Alessi, I ; Altini, C ; Mastronuzzi, A ; Villani, M F ; Cefalo, M G ; D'Andrea, M L ; Del Baldo, G ; Locatelli, F ; Cannata, V ; De Ioris, M A ; Fabozzi, F ; Di Giannatale, A ; Lanzaro, F ; Serra, A ; Pizzoferro, M

BACKGROUND:

The prognosis of relapsed/refractory (R/R) neuroblastoma (NB) is still dismal. The role of iodine-131 meta-iodobenzylguanidine (¹³¹I-mIBG) treatment as a tool to reduce tumour burden before novel immunotherapies is not defined.

PATIENTS AND METHODS:

Patients with R/R NB were included in a prospective observational study based on two infusions of ¹³¹I-mIBG plus melphalan (110 mg/m²), supported by autologous haematopoietic stem cell rescue. The activity of the first administration was 444 MBq (12 mCi/kg), while the second dose was modulated to reach a whole-body absorbed dose of 4 Gy. The International Neuroblastoma Response Criteria (INRC) were used for response.

RESULTS:

Twenty-six patients with a median age of 5.9 years (range 2.5-17.2 years) were treated. Twenty-three patients presented a bone/bone marrow involvement, and 21 patients presented an uptake at primary site or at soft-tissue sites. The median International Society of Paediatric Oncology Europe Neuroblastoma Group (SIOPEN) skeletal score was 10 (range 1-70). The main recorded toxicities were haematological, with no toxic deaths and only one grade 4 mucositis. Hypothyroidism was reported in 6 patients of the 14 alive patients. The overall response rate was 48% [95% confidence interval (CI) 28% to 69%] with only one progression; after treatment the median SIOPEN skeletal score was 6 (range 0-70) with a median reduction of 35% (range 4.3%-100%). Overall, 52% (95% CI 32% to 73%) of patients achieved/maintained a SIOPEN skeletal score <7 and a soft-tissue lesion <5 cm was seen in 67% (95% CI 43% to 91%). After this treatment, 65% of patients underwent GD2-targeting chimeric antigen receptor (CAR)-T-cell therapy and 50%, high-dose chemotherapy with busulfan and melphalan. The 3-year overall survival was 55% (95% CI 33% to 73%) and event-free survival was 42% (95% CI 23% to 60%).

CONCLUSION:

The ¹³¹I-mIBG therapy plus melphalan is confirmed to be effective to reduce/control tumour burden. Further studies are needed to clarify the role and timing of this treatment and to integrate its role in the strategy of CAR-T cells.

2025-03-01·JOURNAL OF RADIOLOGICAL PROTECTION

Harmonization of practice of release of patients after radiopharmaceutical therapy

Article

作者: Vodovatov, Aleksandr ; Chipiga, Larisa ; Vazhenina, Daria ; Stanzhevskiy, Andrey ; Likhacheva, Anastasia ; Maystrenko, Dmitrii ; Zvonova, Irina

Abstract:

The implementation of novel therapeutic radiopharmaceuticals requires developing, updating, and harmonizing requirements for radiation safety in radiopharmaceutical therapy (RPT). Public exposure from patients with administered radiopharmaceuticals and biological radioactive waste management have been identified as the main problems in RPT. The aim of our study was to compare different approaches to the development of patient release criteria after RPT with different radiopharmaceuticals, considering radiation exposure of members of the public in transport, biological elimination of radionuclides from a patient’s body, and the generation of biological waste. The study was performed for the following radiopharmaceuticals: 177Lu-PSMA-617, 177Lu-DOTATATE, Na131I, 131I-mIBG, and 153Sm-oxabifor. Two base approaches to patient release criteria were considered. The first approach is based on the radioactive decay of radionuclides and is divided into two groups: considering one radiopharmaceutical administration and considering several radiopharmaceutical administrations per course. The second approach is based on the radioactive decay of radionuclides and biological elimination of radiopharmaceuticals from the patient’s body (effective half-life) and is divided into groups based on 1 and 5 mSv dose constraints per course. The ffective dose rates from patients and sewage tanks to passengers and staff on public transport were estimated for various scenarios of patients traveling after RPT. The results demonstrated that the radiation safety of members of the public in transport should be considered when establishing the release criteria of patients after RPT. Based on the results, it is recommended to follow the approach based on the radioactive decay of radionuclides and dose constraints to members of the public in contact with patients of 1 mSv per radiopharmaceutical administration, and keep patients in the nuclear medicine department after radiopharmaceutical administration for at least 4–6 h. The patient release criteria defined according to this approach comply with patient release criteria used in different countries, and allow the radiation safety of the public to be maintained.

2025-03-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

131I-mIBG therapy in relapsed/refractory neuroblastoma: A weapon from the future past

Review

作者: Drago, Margherita ; Pizzoferro, Milena ; Del Bufalo, Francesca ; De Ioris, Maria Antonietta ; Fabozzi, Francesco ; Altini, Claudio ; Di Giannatale, Angela ; Davide, Ciucci ; Garganese, Maria Carmen ; Mastronuzzi, Angela ; Cannatà, Vittorio ; Villani, Maria Felicia ; D'Antonio, Federica ; Triumbari, Elizabeth Katherine Anna ; Vennarini, Sabina

Neuroblastoma (NB) is the most common extracranial solid tumor in children, with variable outcomes ranging from spontaneous remission to high-risk cases often leading to relapse or refractory disease. Approximately 50 % of patients with NB have high-risk features, often experiencing relapse or refractory disease despite intensive treatments and the prognosis remains poor, with long-term event-free survival (EFS) rates below 10 %,Radioactive iodine-labeled meta-iodobenzylguanidine (¹³¹I-mIBG) therapy, leveraging NB cells' radiosensitivity and expression of the norepinephrine transporter (NET), has shown promise in treating relapsed or refractory NB. Since 1985, ¹³¹I-mIBG has been studied to determine the maximum tolerated dose and side effects, with recent trials exploring its use in front-line treatment. Our systematic review, based on MEDLINE, EMBASE, and Cochrane CENTRAL databases up to December 2023, evaluates the effectiveness and toxicity of ¹³¹I-mIBG therapy in relapsed/refractory NB. It also discusses its potential role in conjunction with emerging therapies like CAR-T cells, haploidentical stem cell transplantation, and dinutuximab beta.

项与碘[131I]苄胍相关的新闻（医药）

2025-02-12

·学术经纬

Nature Medicine | 异体GD2 CAR-T在治疗高危神经母细胞瘤中展现出希望

撰文 | 周叶斌即使采用强化的多模式治疗，50%至60%的高危神经母细胞瘤 (HR-NB) 患者的肿瘤反应不佳或会遇到复发。而复发或难治性 (r/r) HR-NB的预后不佳，长期无病生存率不超过10-15%。因此目前仍需探索新的治疗方案，例如CAR-T治疗。此前，NCT03373097这项I/II期临床试验的中期分析显示，靶向GD2的第三代 (CD28-4.1BB) CAR-T，GD2-CART01这种自体CAR-T疗法可能是 r/r HR-NB患者的潜在选择。尤其值得注意的是，在那项研究中，输注时疾病负担较低的患者在用GD2-CAR T细胞治疗时疗效显著，3年无事件生存率接近 60%。但实现低肿瘤负担可能需要使用HD化疗或间碘苄胍（MIBG）疗法，而对于无法采集自体干细胞的患者，则不能使用这些疗法。此外，一部分患者由于严重的淋巴细胞减少而无法获得自体CAR-T细胞。近日，来自意大利的研究团队在 Nature Medicine 上发表了题为 Donor-derived GD2-specific CAR T cells in relapsed or refractory neuroblastoma 的论文，在NCT03373097 自体CAR-T治疗神经母细胞瘤的基础上，探索用同种异体GD2-CAR T细胞（ALLO_GD2-CART01）治疗r/r HR-NB。在5例患者中观察到2例完全缓解，一例维持缓解，显示出初步希望，也意味着ALLO_GD2-CART01 对 r/r HR-NB 儿童的安全性和有效性值得在前瞻性试验中进一步研究。 2022年2月到2024年1月，研究人员用ALLO_GD2-CART01治疗了5名r/r HR-NB患者。所有患者的肿瘤都对超过3线的治疗不再有应答，包括两人接受过自体GD2-CART01治疗。使用ALLO_GD2-CART01治疗的原因包括已经没有其它治疗选择，潜在的治愈可能以及过往自体CAR-T治疗失败。值得注意的是5位患者都成功接受了ALLO_GD2-CART01治疗，没有患者中途退出。附图. 5位患者的治疗流程已为所有五名患者成功生产ALLO_GD2-CART01，所用生产工艺与自体GD2 CAR-TAUTO_GD2-CART01相同。ALLO_GD2-CART01 生产结束时的中位T细胞数为3.85 × 10^9（范围2.4 – 4.76 × 10^9），中位转导效率和细胞存活率分别为 70.1%（范围 62.8–76.5%）和 94.4%（范围 88.5–96.7%）。生产出来的ALLO_GD2-CART01特点是CD4或CD8中央记忆CAR阳性T细胞占主导，与AUTO_GD2-CART01药物产品相比，幼稚CD4 CAR阳性T细胞和幼稚和终末分化效应记忆CAR阳性CD8 T细胞百分比较低。 ALLO_GD2-CART01在患者 1中于HSCT（干细胞移植）后第 62 天输注，在患者3中于第72天输注，在患者4中于第 73 天输注，在患者 5 中于HSCT后2.5年输注，而患者 2 则在HSCT前89天接受了从 HLA 相合兄弟姐妹产生的基因工程 T 细胞（该患者接受异基因 HSCT 是为了治疗 ALLO_GD2-CART01 后出现的长期严重的血细胞减少症）。在四名患者中观察到对ALLO_GD2-CART01的反应，其中患者2和4中获得2次CR（尽管输注前观察到大量进展），患者5中1次维持CR，患者 3中1 次部分反应（PR），两个软组织病变缩小，MIBG 骨骼评分降低 50% 以上。附图. 部分患者治疗效果在患者4中，鉴于获得的结果、良好的安全性和疾病特有的非常高的风险，研究人员决定在第一次输注后的第8周输注第二剂 ALLO_GD2-CART01（3 × 10^6 CAR阳性细胞/kg），考虑到患者仍然处于细胞减少症，无需先前进行淋巴细胞清除。患者2最初接受自体CAR-T治疗，观察到的最佳反应为 SD，反应持续时间为 6 个月，而在接受ALLO_GD2-CART01 后，最终获得CR。患者3接受AUTO_GD2-CART01后获得的最佳反应是 PR，持续时间为 15 个月。在此期间，患者还接受了放射治疗。在随后的复发后，她又接受了两次AUTO_GD2-CART01输注，但证明具有抗药性。然后研究人员决定继续进行 ALLO_GD2-CART01 输注，获得了新的PR。尽管取得了这些成果，但前四名患者的病情随后复发或进展。特别是患者1在接受 ALLO_GD2-CART01 治疗 6 个月后病情进展，出现新的肝病变。患者2在HSCT后4个月观察到两个新的骨斑，但直到输注后 24 个月进行的最后一次评估时，尽管没有任何其他治疗，骨斑仍未进展。患者3在输注ALLO_GD2-CART01 3 个月后观察到病情进展。患者4在输注3.5个月后观察到疾病在中枢神经系统中大规模扩散。患者5在接受 ALLO_GD2-CART01 治疗6个月后仍保持持续CR。在安全性方面，所有患者中均观察到与自体产品常见的毒性反映。特别是在所有儿童中均观察到≥3 级血液学毒性，第2，4，5位患者经历了长时间（>4 周）的中性粒细胞减少症。所有患者均出现了细胞因子释放综合征（CRS），并与血清细胞因子（包括 CXCL9 和 CXCL10）的增加有关，这些细胞因子的水平又与患者随访期间和 CAR T 细胞体内扩增时干扰素增加相关。在同样与使用过自体CAR-T治疗2、3号患者中，参考CRS分级和IL-6 细胞因子升高水平，均是接受ALLO_GD2-CART01治疗时CRS的严重程度更高，这表明来自同种异体的CAR-T细胞活化更强。为了进一步了解ALLO_GD2-CART01的生物学特性，研究人员将RNA-seq分析获得的五个药物产品的转录组谱与在随访扩增高峰期从患者中收集和分离出的CAR-T细胞进行比较。在所有分析的基因中，有 2,725 个基因表达存在差异，其中 1,204 个基因在随访中上调。附图. 药物产品与随访时采集的CAR-T细胞基因表达差异在与药物产品相比，随访样本中上调差异表达最高的基因中观察到多个与T细胞活化和迁移相关的基因，包括CASZ1、GZMK 、WHAMM和RAP1GAP2（参与肌动蛋白细胞骨架的组织和膜运输，与CAR-T细胞粘附于靶细胞和突触形成有关）、ATG2A和TP53INP1（参与自噬，对CAR-T细胞在压力下的存活和功能至关重要）VCAM1 （参与细胞粘附、迁移，对CAR-T细胞运输和肿瘤浸润很重要）、FGR（一种免疫反应的酪氨酸激酶，对CAR-T细胞活化和信号传导很重要）和LYST （调节溶酶体的大小和功能，对CAR-T细胞的功能和细胞毒性很重要）。总之，这项研究显示在异质性患者群体中使用 ALLO_GD2-CART01是可行的，具有可接受的毒性特征和治疗这些多次复发的 HR-NB 患者的疗效证据。考虑到这五名患者所表现出的可行性和安全性，ALLO_GD2-CART01 可能为传统的 AUTO_GD2-CART01 提供替代方案。尽管这项研究存在局限性，特别是样本量很小，只有五名患者接受了治疗。此外，既往治疗的高度异质性使得结果难以推广。但在所述晚期疾病患者病例系列中，该方法表现出令人鼓舞的安全性和抗肿瘤活性，值得在正式的 I/II 期临床试验中对ALLO_GD2-CART01进行进一步的前瞻性研究。撰文制作排版 | 车洁校对 | uu 延伸阅读 GD2 CAR-T治疗髓母细胞瘤最新进展神经母细胞瘤的免疫新疗法：PC-CAR T疗法 *本文由深圳市拾玉儿童公益基金会“儿童肿瘤前沿”团队编译或约稿，文中图表均源引自文献原文。本文著作权归文章作者所有，欢迎个人转发分享，未经允许禁止转载，作者拥有所有法定权利，违者必究。如需转载，请留言或联系shiyu@curekids.cn。本文旨在分享儿童肿瘤科研前沿成果，不是治疗方案推荐。如需获得疾病治疗方案指导，请前往正规医院就诊。 ▼滑动查看更多▼ 原文摘要（Abstract） Allogeneic chimeric antigen receptor (CAR) T cells targeting disialoganglioside-GD2 (ALLO_GD2-CART01) could be a therapeutic option for patients with relapsed or refractory, high-risk neuroblastoma (r/r HR-NB) whose tumors did not respond to autologous GD2-CART01 or who have profound lymphopenia. We present a case series of five children with HR-NB refractory to more than three different lines of therapy who received ALLO_GD2-CART01 in a hospital exemption setting. Four of them had previously received allogeneic hematopoietic stem cell transplantation. All patients experienced grade 2 or 3 cytokine release syndrome and one grade 2 neurotoxicity. Moderate acute graft-versus-host-disease occurred in four patients. ALLO_GD2-CART01 persisted for >6 weeks. Post-treatment, two complete responses were achieved and one maintained; in addition, one partial response and one stable disease were observed. Comparing the transcriptomic profiles obtained by RNA sequencing analyses of drug products with patient-matched, peripheral blood ALLO_GD2-CART01 collected at expansion, we found upregulation of genes associated with T cell activation and migration. In addition, after infusion, transcriptomic signaling analysis showed enrichment of genes involved in response to decreased oxygen levels, humoral immune response, cell polarization and immune-synapse formation. In comparison to autologous CAR T cells, ALLO_GD2-CAR T cells were characterized by pathways associated with T cell proliferation, immune-synapse formation and cell chemotaxis. The safety and efficacy of ALLO_GD2-CART01 in children with r/r HR-NB deserve further investigation in a prospective trial. DOI: https://doi.org/10.1038/s41591-024-03449-x 👇点击此处，直达原文

细胞疗法免疫疗法临床结果临床1期

2025-01-29

·Pharmaceutical Technology

Lantheus acquires radiopharma CDMO Evergreen for up to $1bn

The acquisition provides Lantheus access to Evergreen’s radioligand therapy (RLT) manufacturing infrastructure. Credit: Love Employee via Getty Images. US-based radiopharmaceutical company Lantheus has announced a definitive agreement to acquire clinical-stage radiopharma contract development and manufacturing organisation (CDMO) Evergreen Therapeutics. Lantheus will make an upfront payment of $250m, with the potential for an additional $752.5m in milestone payments. This marks Lantheus’ fifth acquisition since January 2024, as it expands its radiopharma capabilities. The acquisition provides Lantheus access to Evergreen’s radioligand therapy (RLT) manufacturing infrastructure, which includes a revenue-generating contract manufacturing business. The company expects this will help supply its clinical trials, scale production for commercial launches, and reduce reliance on third-party manufacturing partners. The deal also brings Octevy, a registrational-stage PET diagnostic being evaluated for detecting neuroendocrine tumours in both adults and paediatric patients. Lantheus said that Octevy could be seen as complementary to PNT2003 (lutetium Lu 177 edotreotide), one of the company’s therapeutic agents co-developed with POINT Biopharma, which is currently in Phase III testing for neuroendocrine tumours. Using radioactive isotopes to diagnose and treat diseases, radiopharmaceuticals have recently gained traction due to their potential in oncology and other indications. However, their development and manufacturing require specialised infrastructure , stringent regulatory compliance, and just-in-time delivery to ensure product efficacy. Manufacturing radiopharmaceuticals has been a key challenge for companies in this space. In August 2023, Lantheus’s subsidiary Progenics discontinued the production of the approved radiopharmaceutical Azedra at its site in Somerset, New Jersey, due to “the combination of limited usage and fixed costs associated with the manufacturing of Azedra”, which made it untenable, as per an SEC filing. With this latest deal, Lantheus noted that Evergreen’s facility is equipped to handle various diagnostic and therapeutic isotopes. Lantheus’ CEO Brian Markison said: “With Evergreen’s manufacturing and development capabilities, we become fully integrated and will ultimately make a difference in the lives of more patients.” This acquisition follows a series of recent transactions by Lantheus aimed at expanding its radiopharmaceutical pipeline. In July 2024, the company acquired Meilleur Technologies, gaining access to an Alzheimer’s PET diagnostic for detecting beta-amyloid plaques in the brain. Earlier this month, Lantheus agreed to acquire Life Molecular Imaging for an upfront payment of $350m, which is expected to support commercial expansion into Alzheimer’s disease diagnostics. The broader radiopharma sector has seen increased investment and consolidation in recent years. In November 2024, Novartis partnered with US-based startup Ratio Therapeutics in a $745m deal to develop a somatostatin receptor 2 (SSTR2) radiotherapeutic for cancer treatment. In May 2024, Novartis acquired Mariana Oncology for $1.75bn, adding radioligand therapy MC-339 to its pipeline. Other major pharma companies such as Bristol Myers Squibb (BMS) and Eli Lilly have also entered the arena, with acquisition deals worth $4.2bn and $1.4bn, respectively. Venture capital investment for US-based companies with radiopharmaceutical drugs saw a rise of 550% between 2017 and 2023, according to GlobalData. GlobalData is the parent company of Pharmaceutical Technology .

并购临床3期

2025-01-27

·Pharmaceutical Technology

MSD wins FDA priority review for Welireg in rare endocrine cancer

PPGL is a group of rare neuroendocrine tumours originating from adrenal gland tissue or paraganglia. Credit: Witthaya Prasongsin via Getty Images. The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to include its use for the treatment of the rare cancer pheochromocytoma and paraganglioma (PPGL). The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of 26 May 2025. The new label is intended to cover adult and paediatric patients aged 12 years and older with advanced, unresectable, or metastatic PPGL. MSD’s submission is based on efficacy and safety data from the Phase II LITESPARK-015 trial (NCT04924075), which evaluated Welireg in patients with advanced PPGL. The study measured the objective response rate (ORR) and duration of response (DOR) as primary endpoints and included other secondary endpoints such as disease control, progression-free survival (PFS), and safety. Results from the trial are expected to be presented at an upcoming medical meeting. MSD acquired Welireg when it bought Peloton Therapeutics for an upfront payment of $1.05bn in 2019. In August 2021, the drug was first approved by the FDA for the treatment of a rare disorder called von Hippel-Lindau (VHL) disease. Welireg is also approved for treating some patients with advanced renal cell carcinoma (RCC). PPGL is a group of rare neuroendocrine tumours originating from adrenal gland tissue or paraganglia. These tumours are often challenging to treat in advanced stages, and current therapeutic options are limited. A gap in the PPGL treatment market was left following the withdrawal of Lantheus ’s Azedra (iobenguane I-131), a radiopharmaceutical therapy approved by the FDA for treating unresectable, locally advanced, or metastatic PPGL requiring systemic anticancer therapy in 2018. Azedra was the first FDA-approved therapy specifically for this rare indication. However, the drug was voluntarily withdrawn from the market due to manufacturing challenges that affected its commercial availability in 2023. Welireg inhibits hypoxia-inducible factor-2 alpha (HIF-2α), thereby targeting pathways involved in tumour growth and survival under low-oxygen conditions. Welireg generated $218m in global sales in 2023, as per MSD’s financials, with expectations to reach up to $1.5bn in annual sales in 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology. Welireg comes with a boxed warning about its potential to cause embryo-foetal harm if used during pregnancy. It can also render hormonal contraceptives ineffective and cause severe anaemia and severe hypoxia.

上市批准优先审批临床2期并购临床结果

100 项与碘[131I]苄胍相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	碘[131I]苄胍	V09IX02	DBSALT002472

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
副神经节瘤	美国	Progenics Pharmaceuticals, Inc.	2018-07-30
嗜铬细胞瘤	美国	Progenics Pharmaceuticals, Inc.	2018-07-30

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10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胃肠胰神经内分泌肿瘤	临床2期	美国	Progenics Pharmaceuticals, Inc.	2022-09-30
高风险神经母细胞瘤	临床2期	美国	Molecular Insight Pharmaceuticals, Inc.	2008-06-01
类癌	临床1期	-	Molecular Insight Pharmaceuticals, Inc.	2006-06-01
转移性消化系统神经内分泌肿瘤 G1	临床1期	-	Molecular Insight Pharmaceuticals, Inc.	2006-06-01
黑色素瘤	临床前	美国	University of Illinois College of Medicine	2012-04-15
神经母细胞瘤	临床前	美国	University of Illinois College of Medicine	2012-04-15

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临床结果

适应症

分期

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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


SNMMI2024	N/A	副神经节瘤	-	I-131 MIBG (Patients with non-avid lesions)	積艱壓鹹範鹹積構餘夢(膚遞鏇繭鹽顧鹹鏇鏇夢) = 鑰蓋憲選繭襯夢糧築醖簾膚鏇壓糧簾糧齋膚廠 (餘糧壓遞鏇鑰鹹襯鏇網, 444.6 ~ 3187.5)	-	2024-06-09
				I-131 MIBG (Patients without non-avid lesions)	積艱壓鹹範鹹積構餘夢(膚遞鏇繭鹽顧鹹鏇鏇夢) = 鬱築鏇鏇廠淵鹽顧夢餘簾膚鏇壓糧簾糧齋膚廠 (餘糧壓遞鏇鑰鹹襯鏇網, 249.9 ~ 1242)
ESPE2023	N/A	甲状腺疾病	-	131 I-metaiodobenzylguanidine (131 I-MIBG)	壓壓齋壓獵觸襯襯壓鏇(簾鏇鹹繭鑰製窪選鬱膚) = ICI-treated children were more sensitive for central hypothyroidism 鏇觸繭餘願糧醖積醖糧 (觸夢壓襯遞網顧醖網餘 ) 更多	-	2023-09-21
OR29-3 (ENDO2022)	N/A	副神经节瘤 \| 嗜铬细胞瘤	24	High-specific-activity 131I-meta-iodobenzylguanidine (HSA 131I-MIBG)	鏇選觸願鏇淵醖顧鏇鑰(遞廠鹹糧餘醖衊鏇糧遞) = fatal gastrointestinal bleeding 廠選願構淵衊鏇襯憲觸 (鹹積糧餘糧夢製夢淵壓 ) 更多	积极	2022-11-01
AZEDRA (SNMMI2022)	N/A	副神经节瘤 \| 嗜铬细胞瘤	24	HSA I-131 MIBG AZEDRA	壓憲築網窪夢築齋夢艱(淵齋遞蓋簾選蓋襯簾獵) = 壓膚遞淵獵壓鹹鬱顧鑰簾廠築糧憲齋繭糧願醖 (鑰顧築襯艱構築壓窪製, 46 ~ 94) 更多	积极	2022-08-08
SNMMI2022	N/A	副神经节瘤 \| 嗜铬细胞瘤	-	I-131 MIBG (High MTV)	選鹽窪鑰蓋鑰憲構蓋壓(選襯鏇鹹鏇齋範顧繭醖) = 選衊蓋鹽顧襯製艱遞網遞餘鏇夢淵鹽窪廠蓋艱 (壓餘糧構製蓋壓壓顧製 )	-	2022-08-08
				I-131 MIBG (High TLG)	鬱襯鹹夢餘壓衊網鏇製(膚醖鏇鏇鏇衊製襯衊繭) = 壓鏇醖遞製衊艱糧選醖鹹廠鹽簾築願網鹹願鑰 (艱製膚餘築鬱憲築憲觸 )
NCT02035137 (NANT Consortium \| N2011-01 \| NANT11-01, CTgov)	临床2期	复发性神经母细胞瘤	114	131I-MIBG (Single-Agent 131I-MIBG)	鏇夢鬱糧壓鹹積獵憲鏇 = 繭窪糧鹽齋膚鏇齋簾願蓋製構範鹹築繭齋糧繭 (鑰壓鬱鹽構鬱鹹繭鬱顧, 壓夢範鑰網膚衊構鏇餘 ~ 鬱網製憲鹽觸鏇獵選製) 更多	-	2022-06-08
				131I-MIBG+irinotecan+Vincristine (131I-MIBG With Vincristine/Irinotecan)	鏇夢鬱糧壓鹹積獵憲鏇 = 壓築觸遞壓夢繭壓襯獵蓋製構範鹹築繭齋糧繭 (鑰壓鬱鹽構鬱鹹繭鬱顧, 簾簾積積選製選憲鹹淵 ~ 糧淵鬱齋製觸觸壓膚窪) 更多
NCT03332667 (ASCO2022) 人工标引	临床1期	难治性神经母细胞瘤	31	GM-CSF+dinutuximab+131I-MIBG 12 mCi/kg (DL1)	繭鑰積鏇艱製觸鹽糧鹽(鑰衊蓋壓襯膚範製鏇簾) = The RP2D of MIBG in combination with standard doses of dinutuximab and GM-CSF is 18 mCi/kg 醖蓋醖壓鹽鑰網膚蓋鹽 (膚簾鑰醖觸糧艱簾鹽選 ) 更多	积极	2022-06-02
				GM-CSF+dinutuximab+131I-MIBG 15 mCi/kg (DL2)
P525 (EBMT2022)	N/A	高风险神经母细胞瘤	-	Auto-HSCT with 18 mCi/Kg 131 I-MIBG	衊廠醖鑰簾積醖壓醖願(選蓋鏇鬱鹹鹽憲鏇觸製) = infections and VOD; in seven and two patients, respectively 顧觸艱繭遞願淵齋鏇鏇 (糧鬱簾蓋醖網選鬱齋遞 )	-	2022-03-19
EANM2021	临床1/2期	高风险神经母细胞瘤	8	High-dose 131I-meta-iodobenzylguanidine Therapy	觸廠蓋觸鑰遞簾夢糧簾(選網鹹顧鬱蓋鹽網築願) = no DLT 顧鑰範網網鑰獵鏇遞鑰 (鏇窪壓廠蓋觸獵範廠範 ) 更多	积极	2021-09-24
				Single High-dose Chemotherapy (HDC)
EANM2021	N/A	神经母细胞瘤 \| 嗜铬细胞瘤	-	124I-MIBG dosimetry guided high activity 131I-MIBG therapy	網鏇積蓋醖簾鹽鹹顧憲(築醖網構糧簾鏇獵獵構) = manageable grade 3 hematological toxicity, which resolved within 12 months after the therapy 鑰簾艱網鏇淵鏇鹹顧簾 (顧餘製觸遞蓋醖構廠醖 ) 更多	积极	2021-09-24