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更新于：2025-02-24
68Ga-FAPI
更新于：2025-02-24
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最高研发阶段终止临床2期 |
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28
项与 68Ga-FAPI 相关的临床试验ChiCTR2400093842
Clinical Translational IIT Study of Novel Radiopharmaceutical Targeting FAP—Evaluating the Clinical Imaging of 68Ga-FAPI-GP PET in Patients with Malignant Solid Tumors
开始日期2024-12-23 |
申办/合作机构- |
NCT06160271
Pilot Study of Liver Fibrosis Stage Assessment by Tep Fibroblast Activation Protein Imaging (68Ga-FAPI-46 TEP/TDM) in Patients With Biopsy for Suspected or Proven Nonalcoholic Steatohepatitis (NASH)
Non-alcoholic fatty liver disease (NAFLD), estimated to be 17% prevalent in France, can lead to non-alcoholic steatohepatitis (NASH), which in turn can progress to fibrosis, the ultimate stage of which is cirrhosis, a major cause of liver transplantation. The prevalence of NASH is increasing worldwide, along with that of type 2 diabetes and obesity. Significant liver fibrosis is estimated to affect at least 2.6% of the adult population in France.
The prognosis of patients with NASH is directly linked to the stage of liver fibrosis determined by biopsy, and these biopsies must now be repeated to assess the effect of treatments. Hepatic fibrosis is traditionally classified into five stages, from the absence of fibrosis (F0) to severe cirrhosis (F4), and passage from one stage to another is considered to demonstrate significant variation, likely to impact prognosis.
However, liver biopsy is painful. It can only analyze a very small proportion of liver volume (1/50,000), whereas the distribution of fibrosis is generally heterogeneous. Above all, biopsy is not devoid of risks, primarily hemorrhage, which can sometimes be severe or even fatal.
In line with current recommendations, clinical-biological algorithms, as well as ultrasound elastography or MRI, are used to assess the risk of fibrosis and the value of a liver biopsy. Generally speaking, these tests have the advantage of very good negative predictive values, making it possible to exclude the possibility of significant fibrosis in a large proportion of patients. However, their positive predictive values are weaker, even when these tests are combined. Above all, they do not allow us to follow the evolution of the fibrosis stage over time. This is why liver biopsies remain indispensable for determining the stage and severity of hepatic fibrosis and monitoring its evolution. It is therefore essential to develop more precise, non-invasive methods for accurately assessing the extent of liver fibrosis. This is the objective of the FreSH national cohort, which uses conventional biological techniques and in which our patients will also be included.
The prognosis of patients with NASH is directly linked to the stage of liver fibrosis determined by biopsy, and these biopsies must now be repeated to assess the effect of treatments. Hepatic fibrosis is traditionally classified into five stages, from the absence of fibrosis (F0) to severe cirrhosis (F4), and passage from one stage to another is considered to demonstrate significant variation, likely to impact prognosis.
However, liver biopsy is painful. It can only analyze a very small proportion of liver volume (1/50,000), whereas the distribution of fibrosis is generally heterogeneous. Above all, biopsy is not devoid of risks, primarily hemorrhage, which can sometimes be severe or even fatal.
In line with current recommendations, clinical-biological algorithms, as well as ultrasound elastography or MRI, are used to assess the risk of fibrosis and the value of a liver biopsy. Generally speaking, these tests have the advantage of very good negative predictive values, making it possible to exclude the possibility of significant fibrosis in a large proportion of patients. However, their positive predictive values are weaker, even when these tests are combined. Above all, they do not allow us to follow the evolution of the fibrosis stage over time. This is why liver biopsies remain indispensable for determining the stage and severity of hepatic fibrosis and monitoring its evolution. It is therefore essential to develop more precise, non-invasive methods for accurately assessing the extent of liver fibrosis. This is the objective of the FreSH national cohort, which uses conventional biological techniques and in which our patients will also be included.
开始日期2024-09-01 |
NCT06559371
68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer
The goal of this observational study is to learn whether 68Ga-FAPI PET/CT may be used as a new effective methods for evaluating axillary lymph node efficacy after neoadjuvant treatment for breast cancer. The main question it aims to answer is:
Could 68Ga-FAPI PET/CT effectively evaluate axillary lymph node after neoadjuvant treatment for breast cancer? Participants will have a 68Ga-FAPI PET/CT test between last neoadjuvant therapy and surgery.
Could 68Ga-FAPI PET/CT effectively evaluate axillary lymph node after neoadjuvant treatment for breast cancer? Participants will have a 68Ga-FAPI PET/CT test between last neoadjuvant therapy and surgery.
开始日期2024-08-30 |
申办/合作机构 |
100 项与 68Ga-FAPI 相关的临床结果
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100 项与 68Ga-FAPI 相关的转化医学
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100 项与 68Ga-FAPI 相关的专利（医药）
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22
项与 68Ga-FAPI 相关的文献（医药）2024-03-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine
Diagnostic Accuracy of68Ga-FAPI Versus18F-FDG PET in Patients with Various Malignancies
Article
作者: Pabst, Kim M ; Uhl, Waldemar ; Siveke, Jens T ; Harter, Philipp ; Kasper, Stefan ; Lugnier, Celine ; Nader, Michael ; Stuschke, Martin ; Barbato, Francesco ; Hamacher, Rainer ; Sraieb, Miriam ; Lanzafame, Helena ; Hautzel, Hubertus ; Kesch, Claudia ; Hirmas, Nader ; von Tresckow, Bastian ; Herrmann, Ken ; Hadaschik, Boris ; Fendler, Wolfgang P ; Kümmel, Sherko ; Kessler, Lukas ; Grünwald, Viktor ; Glas, Martin ; Aigner, Clemens
To assess the diagnostic accuracy of 68Ga-labeled fibroblast activation protein inhibitor (FAPI) and 18F-labeled FDG PET for the detection of various tumors, we performed a head-to-head comparison of both imaging modalities across a range of tumor entities as part of our ongoing 68Ga-FAPI PET observational trial. Methods: The study included 115 patients with 8 tumor entities who received imaging with 68Ga-FAPI for tumor staging or restaging between October 2018 and March 2022. Of those, 103 patients received concomitant imaging with 68Ga-FAPI and 18F-FDG PET and had adequate lesion validation for accuracy analysis. Each scan was evaluated for the detection of primary tumor, lymph nodes, and visceral and bone metastases. True or false positivity and negativity to detected lesions was assigned on the basis of histopathology from biopsies or surgical excision, as well as imaging validation. Results: 68Ga-FAPI PET revealed higher accuracy than 18F-FDG PET in the detection of colorectal cancer (n = 14; per-patient, 85.7% vs. 78.6%; per-region, 95.6% vs. 91.1%) and prostate cancer (n = 22; per-patient, 100% vs. 90.9%; per-region, 96.4% vs. 92.7%). 68Ga-FAPI PET and 18F-FDG PET had comparable per-patient accuracy in detecting breast cancer (n = 16, 100% for both) and head and neck cancers (n = 10, 90% for both modalities). 68Ga-FAPI PET had lower per-patient accuracy than 18F-FDG PET in cancers of the bladder (n = 12, 75% vs. 100%) and kidney (n = 10, 80% vs. 90%), as well as lymphoma (n = 9, 88.9% vs. 100%) and myeloma (n = 10, 80% vs. 90%). Conclusion: 68Ga-FAPI PET demonstrated higher diagnostic accuracy than 18F-FDG PET in the diagnosis of colorectal cancer and prostate cancer, as well as comparable diagnostic performance for cancers of the breast and head and neck. Accuracy and impact on management will be further assessed in an ongoing prospective interventional trial (NCT05160051).
2024-03-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine
Design, Preclinical Evaluation, and Clinical Translation of68Ga-FAPI-LM3, a Heterobivalent Molecule for PET Imaging of Nasopharyngeal Carcinoma
Article
作者: Lin, Qin ; Sun, Long ; Chen, Jianhao ; Guo, Zhide ; Pang, Yizhen ; Chen, Haojun ; Zhou, Yangfan ; Zhao, Liang ; Fang, Jianyang ; Wu, Hua
Extensive research has been conducted on radiolabeled fibroblast activation protein (FAP) inhibitors (FAPIs) and p-Cl-Phe-cyclo(d-Cys-Tyr-d-4-amino-Phe(carbamoyl)-Lys-Thr-Cys)d-Tyr-NH2 (LM3) peptides for imaging of FAP and somatostatin receptor 2 (SSTR2)-positive tumors. In this study, we designed and synthesized a FAPI-LM3 heterobivalent molecule radiolabeled with 68Ga and evaluated its effectiveness in both tumor xenografts and patients with nasopharyngeal carcinoma (NPC). Methods: The synthesis of FAPI-LM3 was based on the structures of FAPI-46 and LM3. After radiolabeling with 68Ga, its dual-receptor-binding affinity was evaluated in vitro and in vivo. Preclinical studies, including small-animal PET and biodistribution evaluation, were conducted on HT-1080-FAP and HT-1080-SSTR2 tumor xenografts. The feasibility of 68Ga-FAPI-LM3 PET/CT in a clinical setting was evaluated in patients with NPC, and the results were compared with those of 18F-FDG. Results: 68Ga-FAPI-LM3 showed high affinity for both FAP and SSTR2. The tumor uptake of 68Ga-FAPI-LM3 was significantly higher than that of 68Ga-FAPI-46 and 68Ga-DOTA-LM3 in HT-1080-FAP-plus-HT-1080-SSTR2 tumor xenografts. In a clinical study involving 6 NPC patients, 68Ga-FAPI-LM3 PET/CT showed significantly higher uptake than did 18F-FDG in primary and metastatic lesions, leading to enhanced lesion detectability and tumor delineation. Conclusion: 68Ga-FAPI-LM3 exhibited FAPI and SSTR2 dual-receptor-targeting properties both in vitro and in vivo, resulting in improved tumor uptake and retention compared with that observed with monomeric 68Ga-FAPI and 68Ga-DOTA-LM3. This study highlights the clinical feasibility of 68Ga-FAPI-LM3 PET/CT for NPC imaging.
2024-02-15·The Journal of clinical investigation
68Ga-FAPI PET imaging monitors response to combined TGF-βR inhibition and immunotherapy in metastatic colorectal cancer
Article
作者: Sun, Yuyun ; Li, Ke ; Liu, Wei ; Qi, Ming ; Wang, Jianpeng ; Xu, Xiaoping ; Tang, Wenxuan ; Song, Shaoli ; Chen, Jiwei ; Tang, Shuang ; Yu, Hang ; Li, Xinxiang ; Guo, Weijian ; Zhang, Ji ; Li, Xiaoling
BACKGROUNDImproving and predicting tumor response to immunotherapy remains challenging. Combination therapy with a transforming growth factor-β receptor (TGF-βR) inhibitor that targets cancer-associated fibroblasts (CAFs) is promising for the enhancement of efficacy of immunotherapies. However, the effect of this approach in clinical trials is limited, requiring in vivo methods to better assess tumor responses to combination therapy.METHODSWe measured CAFs in vivo using the 68Ga-labeled fibroblast activation protein inhibitor-04 (68Ga-FAPI-04) for PET/CT imaging to guide the combination of TGF-β inhibition and immunotherapy. One hundred thirty-one patients with metastatic colorectal cancer (CRC) underwent 68Ga-FAPI and 18F-fluorodeoxyglucose (18F-FDG) PET/CT imaging. The relationship between uptake of 68Ga-FAPI and tumor immunity was analyzed in patients. Mouse cohorts of metastatic CRC were treated with the TGF-βR inhibitor combined with KN046, which blocks programmed death ligand 1 (PD-L1) and CTLA-4, followed by 68Ga-FAPI and 18F-FDG micro-PET/CT imaging to assess tumor responses.RESULTSPatients with metastatic CRC demonstrated high uptake rates of 68Ga-FAPI, along with suppressive tumor immunity and poor prognosis. The TGF-βR inhibitor enhanced tumor-infiltrating T cells and significantly sensitized metastatic CRC to KN046. 68Ga-FAPI PET/CT imaging accurately monitored the dynamic changes of CAFs and tumor response to combined the TGF-βR inhibitor with immunotherapy.CONCLUSION68Ga-FAPI PET/CT imaging is powerful in assessing tumor immunity and the response to immunotherapy in metastatic CRC. This study supports future clinical application of 68Ga-FAPI PET/CT to guide precise TGF-β inhibition plus immunotherapy in CRC patients, recommending 68Ga-FAPI and 18F-FDG dual PET/CT for CRC management.TRIAL REGISTRATIONCFFSTS Trial, ChiCTR2100053984, Chinese Clinical Trial Registry.FUNDINGNational Natural Science Foundation of China (82072695, 32270767, 82272035, 81972260).
3
项与 68Ga-FAPI 相关的新闻（医药）2025-02-16
01. 背景简介
2025年2月，厦门大学附属第一医院核医学科陈皓鋆教授及新加坡国立大学陈小元教授、张静静教授团队在肿瘤学顶级期刊《Clinical Cancer Research》（JCR Q1区，IF=11.5）正式发表了题为“177Lu-LNC1004 Radioligand Therapy in Patients with End-Stage Metastatic Cancers: A Single-Center, Single-Arm, Phase II Study” 的研究论文。该研究探讨了针对晚期转移性癌症患者的177Lu-LNC1004放射性配体治疗（RLT）的疗效和安全性，涉及的肿瘤类型包括转移性甲状腺癌（45%）、乳腺癌（10%）、神经内分泌癌（7%）、肉瘤（7%）等。原文链接：DOI: 10.1158/1078-0432.CCR-24-3918
相关往期链接：
重磅：东诚核药177Lu-LNC1004首次人体剂量递增研究！
02. 研究方法
癌症相关成纤维细胞（CAFs）在肿瘤微环境中起着关键作用，它们通过高表达纤维细胞激活蛋白（FAP）促进肿瘤的发展和转移。FAP在正常组织中几乎不表达，因此被视为一种理想的肿瘤靶点。尽管癌症治疗取得了显著进展，但许多患者仍面临治疗抵抗和疾病进展的挑战。FAP靶向放射性配体治疗（RLT）通过靶向FAP阳性的CAFs和肿瘤细胞，利用“交叉火力效应”实现对肿瘤及其微环境的双重打击。然而，以往的FAP靶向放射性配体由于在肿瘤中的快速清除，限制了其治疗潜力。本研究中使用的177Lu-LNC1004通过结合伊文氏蓝（Evans Blue, EB）延长了药物在血液中的循环时间，从而增强了药物在肿瘤中的保留和治疗效果。
★研究设计
研究类型：单中心、单臂、II期临床试验。
患者筛选：2022年6月至2024年4月，共筛选50名患者，最终28名符合条件的患者入组。
入组标准：
患者年龄>18岁，患有进展性转移性癌症。
所有标准治疗均已用尽。
通过68Ga-FAPI-46 PET/CT筛查，>50%转移病灶 SUVmax≥10。
排除标准：包括严重的肝肾功能异常、血液学异常、心脏功能不全等。
★治疗方案
放射性药物：177Lu-LNC1004，剂量为3.33 GBq/周期，每6周进行一次治疗，计划进行4个周期。
治疗过程：
患者在治疗前接受4 mg昂丹司琼（Ondansetron）预防恶心呕吐。
治疗前30分钟静脉输注1 L生理盐水。
177Lu-LNC1004通过静脉输注，输注时间为20-30分钟。
治疗期间和治疗后密切监测患者的症状和生命体征。
★研究终点
主要终点：疗效评价（RECIST 1.1标准）。
次要终点：无进展生存期（PFS）、总生存期（OS）、剂量学分析和安全性。
03. 研究结果
研究结果显示，177Lu-LNC1004放射性配体治疗在晚期转移性癌症患者中表现出良好的疗效和安全性。在28名入组患者中，部分患者未完成疗效评估。在20名可评估的患者中，疾病控制率（DCR）为46%（13/28），其中部分缓解（PR）率为20%（4/20），稳定疾病（SD）率为45%（9/20）。治疗后，患者的中位无进展生存期（PFS）为4.0个月，中位总生存期（OS）为6.3个月。剂量学分析显示，肿瘤的平均吸收剂量为4.69±3.83 Gy/GBq，表明177Lu-LNC1004在肿瘤中具有良好的保留和治疗潜力。在安全性方面，未观察到严重的肝肾毒性。3/4级血液毒性发生率为21%，主要为血小板减少（29%）、白细胞减少（7%）和中性粒细胞减少（7%）。这些不良事件大多与患者的晚期癌症状态和既往治疗有关，整体耐受性良好。这些结果表明，177Lu-LNC1004 RLT不仅在多种晚期癌症中具有显著的抗肿瘤效果，还为标准治疗失败的患者提供了新的治疗选择。
图2展示了177Lu-LNC1004在患者体内的分布情况。这位54岁女性平滑肌肉瘤患者在经历了两次手术，并接受了化疗、酪氨酸激酶抑制剂和PD-1免疫检查点抑制剂治疗后疾病仍持续进展。治疗前的68Ga-FAPI-46 PET/CT扫描显示其转移病灶（包括腹膜和肺部）对示踪剂有高摄取。患者随后接受了3.33 GBq的177Lu-LNC1004放射性配体治疗。治疗后的全身扫描显示，177Lu-LNC1004在肿瘤中具有良好的摄取和保留，肿瘤病灶的平均吸收剂量为4.69±3.83 Gy/GBq。随访的PET/CT扫描显示，肿瘤病灶的示踪剂摄取显著减少，疾病评估为稳定（SD）。这一案例表明177Lu-LNC1004在控制晚期转移性癌症进展方面具有显著的潜力，尤其是在标准治疗失败的患者中。
图3展示了20名患者的靶病灶直径在治疗前后的变化。通过RECIST 1.1标准评估，4名患者达到部分缓解（PR），9名患者病情稳定（SD），显示出177Lu-LNC1004在控制肿瘤进展方面的显著效果。
图4通过两个典型病例，展示了177Lu-LNC1004治疗前后的68Ga-FAPI-46 PET/CT影像变化。第一位患者是一位60岁女性，患有转移性乳腺癌，尽管之前接受了手术、化疗和内分泌治疗，但病情仍在进展。治疗前的68Ga-FAPI-46 PET/CT扫描显示其纵隔淋巴结、胸椎和肝脏转移病灶有强烈的示踪剂摄取。经过两周期177Lu-LNC1004治疗后，随访PET/CT显示这些病灶的大小和示踪剂摄取显著减少，根据RECIST 1.1标准评估为疾病稳定（SD）。第二位患者是一位55岁女性，患有髓样甲状腺癌并伴有广泛骨转移，之前接受过酪氨酸激酶抑制剂治疗但病情仍在进展。治疗前的PET/CT扫描显示其骨转移病灶有强烈的示踪剂摄取。经过两周期177Lu-LNC1004治疗后，随访PET/CT显示病灶大小缩小，示踪剂摄取显著减少，评估为部分缓解（PR）。这两个案例均表明177Lu-LNC1004在晚期转移性癌症患者中具有显著的抗肿瘤效果，能够显著缩小病灶并降低示踪剂摄取，为标准治疗失败的患者提供了新的治疗选择。
图5展示了接受177Lu-LNC1004放射性配体治疗（RLT）的晚期转移性癌症患者的生存分析结果。研究中，28名患者的中位无进展生存期（PFS）为4.0个月，中位总生存期（OS）为6.3个月。进一步的生存分析显示，根据RECIST 1.1标准，达到疾病控制（部分缓解PR和稳定疾病SD）的患者，其PFS和OS显著延长，分别为16.3个月和18.4个月，而疾病进展（PD）或未评估的患者PFS和OS较短。这一结果表明，177Lu-LNC1004 RLT能够显著延长患者的生存期，尤其是在实现疾病控制的患者中，进一步证实了其在晚期转移性癌症治疗中的临床价值。
04. 小结
★创新性：本研究首次在多种晚期转移性癌症患者中评估了177Lu-LNC1004 RLT的疗效和安全性，为FAP靶向治疗提供了新的临床数据。
★疗效显著：研究显示，177Lu-LNC1004在多种晚期癌症中表现出良好的抗肿瘤效果，疾病控制率达到46%，显著延长了患者的无进展生存期（PFS）和总生存期（OS）。
★安全性高：177Lu-LNC1004的毒性较低，未观察到严重的肝毒性和肾毒性，治疗相关3/4级血液毒性发生率为21%，整体耐受性良好。
★临床意义：研究结果为FAP靶向放射性配体治疗的临床应用提供了重要依据，尤其是在标准治疗失败的患者中，177Lu-LNC1004 RLT显示出显著的治疗潜力。
文末附上了原文链接，方便读者检索拜读。
●新核药助力乳腺癌精准诊疗——CDK4/6成像新突破！
●PSMA靶向核药[177Lu]Lu-SibuDAB在mCRPC患者中的生物分布和剂量学研究结果
●2025开年巨献：核药发展现状全景解析！
●GLP1受体靶向新核药的临床研究！
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临床2期放射疗法临床结果
2024-10-17
·梅斯医学
正电子发射断层扫描/计算机断层扫描（PET/CT）是一种非常有用的影像学检查手段，其结合了PET的功能性成像与CT的解剖结构成像。对于EB病毒（Epstein-Barr Virus, EBV）相关鼻咽癌患者来说，在接受放射治疗后使用PET/CT监测复发情况是非常重要的。对于监测EB病毒相关鼻咽癌复发患者，常用的显像剂有 18F-FDG 和 68Ga-FAPI 等，其中，18F-FDG 是葡萄糖类似物，肿瘤细胞因代谢旺盛会摄取更多的 18F-FDG；68Ga-FAPI 则与肿瘤微环境中的成纤维细胞活化蛋白结合，用于检测肿瘤。虽然PET/CT具有很高的敏感性和特异性，但它也有一定的局限性，比如成本较高、辐射暴露等。
10月19日~23日，2024年第37届欧洲核医学协会年会(EANM) 在德国汉堡隆重召开，来自世界各地的核医学专家汇聚一堂，共同探讨该领域的最新研究成果和临床实践。在本届大会上，来自复旦大学附属肿瘤医院团队发表了一项题为”Head-to-head evaluation of 18F-FDG and 68Ga-FAPI PET/CT in surveillance of postradiotherapy recurrence of EBV-associated nasopharyngeal carcinoma“的研究，旨在探讨68Ga标记的成纤维细胞活化蛋白抑制剂（FAPI）正电子发射断层扫描/计算机断层扫描（PET/CT）在监测鼻咽癌（NPC）放疗后复发方面的潜在作用，并与18F-氟脱氧葡萄糖（18F-FDG）及EB病毒DNA（EBV-DNA）进行比较。
这项前瞻性影像学对比试验在复旦大学附属肿瘤医院进行（ChiCTR2100054163, 中国临床试验注册中心），在2021年8月至2023年4月期间招募了36名EBV-DNA负荷升高或常规影像学（CT或磁共振成像）结果不明确的患者。两名经验丰富的核医学医师记录了局部复发和远处转移的情况。恶性病变通过组织病理学分析及综合参考标准进行了验证。
结果显示，在36名患者中，女性8名，男性28名，中位年龄为50.5岁（29-66岁），有25名（69.44%）患者出现复发并接受了进一步治疗。与EBV-DNA、增强MRI/CT及18F-FDG PET/CT相比，68Ga-FAPI PET/CT显示出最高的诊断准确率 (94.44% vs. 47.22%, 50.00% and 83.33%; p < 0.001, = 0.033 and = 0.004).
对病灶分析中，18F-FDG和68Ga-FAPI PET/CT共检测到78个病灶，其中64个恶性病灶和14个良性病灶。与18F-FDG相比，68Ga-FAPI PET/CT在病灶检测的灵敏度、特异性、阳性预测值、阴性预测值以及准确性方面均表现更优，分别为96.88% vs. 90.63%，64.29% vs. 7.14%，92.54% vs. 81.69%，81.82% vs. 14.29%，和91.03% vs. 75.64%（p=0.004）。
总之，68Ga-FAPI PET/CT在检测局部复发和远处转移方面优于EBV-DNA、增强MRI/CT及18F-FDG PET/CT，可作为EB病毒相关鼻咽癌患者的一种准确、可靠且可重复的监控手段。
参考资料：B. Gu, Z. Yang, S. Song.Head-to-head evaluation of 18F-FDG and 68Ga-FAPI PET/CT in surveillance of postradiotherapy recurrence of EBV-associated nasopharyngeal carcinoma.https://link.springer.com/article/10.1007/s00259-024-06838-z
来源 | 梅斯医学官网
编辑 | Swagpp
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放射疗法临床结果
2023-09-28
·美通社
烟台
2023年9月27日
/美通社/ -- 近日，在奥地利维也纳举行的
第
36届欧洲核医学年会
（EANM'2023，9月9-13日）上，东诚药业控股子公司烟台蓝纳成生物技术有限公司（简称"蓝纳成"）再度展示了
蓝纳成在核素诊疗领域的创新研究成果并受到国际同行的关注和认可
。此次会议中，蓝纳成共有9篇口头汇报（含3篇Feature和6篇TOP）和3篇海报展示，展示了其在核医学研究中的最新进展。EANM是核医学领域全球顶尖的专业会议，汇集了世界各地的核医学专家学者，旨在共享和探讨这一领域的最新科研成果。在这一重要的国际舞台上，此行由蓝纳成创始人兼首席科学官陈小元教授和首席医学官、新加坡国立大学的张静静教授带队，与公司核心团队及合作者一同参与。
以下为此次会议上发布的主要研究亮点：
研究亮点【1】
蓝纳成对于
FAP靶点进行核素诊疗药物开发，当前在全球多中心开展着药物临床转化研究，多项已获得IND批准，蓝纳成首席医学官张静静教授，在会议上热情洋溢地汇报了最新FAP
I
治疗药物的研究。
关于β及α治疗型核素
177
Lu，
90
Y，
225
Ac标记的新型FAP靶向核素药物治疗在多种进展性实体瘤中的首次人体研究的最新进展，这一创新性的研究为蓝纳成未来在FAPI治疗药物的开发提供了有力的技术储备，展现了蓝纳成在开发核素创新治疗药物方面的前沿意识。
研究亮点【2】
177
Lu-LNC1003在转移性去势抵抗性前列腺癌（mCRPC）中的治疗研究：
福建医科大学附属第一医院臧洁医生展示了
177
Lu-LNC1003在mCRPC中的安全性、剂量学及疗效研究。这一首次在人体进行的初步研究显示，与
177
Lu-EB-PSMA和
177
Lu-PSMA-617相比，
177
Lu-LNC1003在肿瘤中的摄取及积累更高，在给予的低剂量下耐受良好。该研究最近也被核医学顶刊European Journal of Nuclear Medicine and Molecular Imaging杂志录用。
研究亮点【3】
177
Lu-LNC1004首次人体剂量学研究：
厦门大学附属第一医院陈皓鋆教授发布了关于
177
Lu-LNC1004（
177
Lu-EB-FAPI）在转移性难治性甲状腺癌患者中首次人体剂量爬坡试验的研究。研究结论指出，
177
Lu-LNC1004在所有患者中均显示良好耐受，并展示出肿瘤摄取增加和滞留时间延长。在3.33-3.7GBq/cycle的剂量下，
177
Lu-LNC1004显示出可以接受的副作用, 高度的肿瘤富集和良好的治疗效果。该研究最近也被癌症研究的顶刊Clinical Cancer Research杂志录用。
研究亮点【4】
68
Ga-LNC1007在恶性肿瘤中的应用：
厦门大学第一附属医院核医学科逄一臻医生汇报了靶向FAP及整合素受体的
68
Ga-LNC1007（
68
Ga-FAPI-RGD）在不同种类恶性肿瘤中的应用。与
18
F-FDG和
68
Ga-FAPI PET/CT相比，
68
Ga-LNC1007展示出更好的肿瘤摄取和肿瘤背景比，显示出在恶性肿瘤诊断及分期中的优势。相关研究在核医学顶刊Journal of Nuclear Medicine和Theranostics等杂志相继发表。
研究亮点【5】
68
Ga-LNC1007在肾癌诊断的效能：
福建医科大学附属医院林荣医生汇报了LNC1007（
68
Ga-FAPI-RGD）在肾癌诊断中的效能研究，并与
18
F-FDG /
68
Ga-PSMA PET/CT进行了对比。研究涉及28名患者，其中25名经病理证实为肾癌。
68
Ga-FAPI-RGD PET/CT在原发病灶检测率上明显优于
18
F-FDG和
68
Ga-PSMA PET/CT。该研究最近也被European Journal of Nuclear Medicine and Molecular Imaging杂志录用。东诚蓝纳成再次以其尖端的研究成果，为核医学和肿瘤诊疗领域带来了创新和突破。蓝纳成将继续加强核医学研发，为患者带来更加精准和有效的诊疗方案。
100 项与 68Ga-FAPI 相关的药物交易
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肿瘤 | 临床2期 | 美国 | 2023-07-01 |
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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 |
|---|
N/A | - | 35 | 範簾繭鹹構壓淵簾蓋廠(醖廠製襯壓築繭廠壓鬱) = 壓糧構鹽鬱蓋簾夢廠簾 膚壓簾壓廠範蓋構糧範 (齋遞鑰餘遞網膚構糧網 ) 更多 | 积极 | 2024-09-27 | ||
N/A | 38 | (Staging cohort) | 廠顧蓋糧獵願廠艱淵餘(構製齋齋醖積鬱醖廠簾) = 艱憲積觸選壓壓糧餘鹽 夢蓋糧淵廠網鏇窪廠構 (蓋鏇構壓鏇簾鬱壓鏇夢 ) | - | 2024-09-27 | ||
(Restaging cohort) | 廠顧蓋糧獵願廠艱淵餘(構製齋齋醖積鬱醖廠簾) = 網醖繭鬱醖簾築糧餘構 夢蓋糧淵廠網鏇窪廠構 (蓋鏇構壓鏇簾鬱壓鏇夢 ) | ||||||
N/A | - | (Ulcerative colitis patients) | 願鹽鑰鬱製壓觸遞餘壓(遞簾網願窪網鏇選積壓) = 範窪鹽願壓窪鬱餘襯夢 製觸糧願製願壓願繭鏇 (鏇製積餘鬱鑰製鏇艱衊 ) | - | 2024-06-09 | ||
N/A | - | 68Ga-FAPI PET/MRI(CT) | 壓襯築鹽鑰選齋範艱範(醖鏇簾遞簾廠壓蓋蓋範) = 壓遞選餘網觸醖艱憲醖 壓遞範構願鏇遞糧衊構 (積窪鬱糧繭餘衊遞構繭 ) | - | 2024-06-09 | ||
N/A | - | (Mass forming pancreatitis (MFP)) | 遞艱壓範憲餘簾獵鹹壓(觸選顧廠糧觸遞繭製遞) = 築築襯鹽繭積積網鏇襯 積網齋範膚淵艱淵簾繭 (遞艱醖壓獵窪夢衊鏇夢 ) | - | 2024-06-09 | ||
(Pancreatic ductal adenocarcinomas (PDAC)) | 遞艱壓範憲餘簾獵鹹壓(觸選顧廠糧觸遞繭製遞) = 夢淵簾壓齋網鑰製簾鹽 積網齋範膚淵艱淵簾繭 (遞艱醖壓獵窪夢衊鏇夢 ) | ||||||
N/A | - | 68Ga-FAPI PET/CT | 積醖製顧積廠夢範憲鑰(餘鏇選遞廠願鬱顧襯觸) = 鹹顧積窪鏇築蓋鹽餘獵 遞觸窪餘網網壓醖膚鹹 (鏇醖蓋構壓衊觸築膚獵 ) | - | 2024-06-09 | ||
18F-FDGPI PET/CT (18F-FDG PET/CT) | 積醖製顧積廠夢範憲鑰(餘鏇選遞廠願鬱顧襯觸) = 簾憲製鹹範顧襯襯鬱鹽 遞觸窪餘網網壓醖膚鹹 (鏇醖蓋構壓衊觸築膚獵 ) | ||||||
N/A | - | 68-Ga FAPI-FAPI (68-Ga FAPI PET/CT) | 製遞遞遞範壓齋醖鏇淵(餘積獵鹹糧齋餘襯窪鬱) = 遞淵壓製鑰夢廠範襯襯 窪鑰壓選鑰積顧鬱遞積 (顧艱鬱壓鏇鹽製壓衊繭 ) 更多 | - | 2024-06-09 | ||
N/A | - | 99mTc-Labeled FAPI Tracer | 範蓋艱鬱襯糧網網遞艱(餘選觸繭鑰鑰糧鏇網簾) = 糧選蓋鏇繭膚淵繭壓獵 鑰積顧製積積鹹築遞鑰 (遞簾廠廠獵壓餘願窪蓋 ) | - | 2023-08-28 | ||
N/A | - | 築憲願網願艱鹽鏇壓餘(襯積淵襯廠鹽選鹹廠製) = 鑰鑰鏇構廠憲鏇襯鏇願 鹽積選鑰願網選淵觸糧 (製範願遞齋築襯壓鬱顧 ) | - | 2022-08-08 | |||
N/A | - | (PAH patients with FAPI uptake in RV) | 築餘壓夢鏇簾範憲觸選(鹹觸築醖繭顧艱鹽鏇獵) = 簾鹹窪艱簾衊襯膚壓衊 糧範醖鑰積製鬱鹹餘顧 (顧壓鹹夢鹽獵膚築遞衊 ) | - | 2022-08-08 | ||
(PAH patients without FAPI uptake in RV) | 築餘壓夢鏇簾範憲觸選(鹹觸築醖繭顧艱鹽鏇獵) = 網壓襯糧鑰夢鹹顧壓網 糧範醖鑰積製鬱鹹餘顧 (顧壓鹹夢鹽獵膚築遞衊 ) |
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