The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

开始日期2018-12-13

申办/合作机构

Universitätsspital Basel

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100 项与 177Lu-PP-F11N 相关的临床结果

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100 项与 177Lu-PP-F11N 相关的转化医学

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100 项与 177Lu-PP-F11N 相关的专利（医药）

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项与 177Lu-PP-F11N 相关的文献（医药）

2020-04-01·Journal of Nuclear Medicine1区 · 医学

Cholecystokinin 2 Receptor Agonist ¹⁷⁷Lu-PP-F11N for Radionuclide Therapy of Medullary Thyroid Carcinoma: Results of the Lumed Phase 0a Study

1区 · 医学

Article

作者: Geistlich, Susanne ; Schibli, Roger ; Kaul, Felix ; McDougall, Lisa ; Nicolas, Guillaume P ; Schumann, Anne ; Glatz, Katharina ; Cachovan, Michal ; Behe, Martin ; Vija, A Hans ; Rau, Tilman ; Rottenburger, Christof ; Christ, Emanuel R ; Wild, Damian

Treatment of patients with advanced medullary thyroid carcinoma (MTC) is still a challenge. For more than 2 decades, it has been known that the cholecystokinin 2 receptor is a promising target for the treatment of MTC with radiolabeled minigastrin analogs. Unfortunately, kidney toxicity has precluded their therapeutic application so far. In 6 consecutive patients, we evaluated with advanced 3-dimensional dosimetry whether improved minigastrin analog ¹⁷⁷Lu-DOTA-(d-Glu)₆-Ala-Tyr-Gly-Trp-Nle-Asp-PheNH₂ (¹⁷⁷Lu-PP-F11N) is a suitable agent for the treatment of MTC. Methods: Patients received 2 injections of about 1 GBq (∼80 μg) of ¹⁷⁷Lu-PP-F11N with and without a solution of succinylated gelatin (SG, a plasma expander used for nephroprotection) in a random crossover sequence to evaluate biodistribution, pharmacokinetics, and tumor and organ dosimetry. An electrocardiogram was obtained and blood count and blood chemistry were measured up to 12 wk after the administration of ¹⁷⁷Lu-PP-F11N to assess safety. Results: In all patients, ¹⁷⁷Lu-PP-F11N accumulation was visible in tumor tissue, stomach, and kidneys. Altogether, 13 tumors were eligible for dosimetry. The median absorbed doses for tumors, stomach, kidneys, and bone marrow were 0.88 (interquartile range [IQR]: 0.85-1.04), 0.42 (IQR: 0.25-1.01), 0.11 (IQR: 0.07-0.13), and 0.028 (IQR: 0.026-0.034) Gy/GBq, respectively. These doses resulted in median tumor-to-kidney dose ratios of 11.6 (IQR: 8.11-14.4) without SG and 13.0 (IQR: 10.2-18.6) with SG; these values were not significantly different (P = 1.0). The median tumor-to-stomach dose ratio was 3.34 (IQR: 1.14-4.70). Adverse reactions (mainly hypotension, flushing, and hypokalemia) were self-limiting and not higher than grade 1. Conclusion: ¹⁷⁷Lu-PP-F11N accumulates specifically in MTC at a dose that is sufficient for a therapeutic approach. With a low kidney and bone marrow radiation dose, ¹⁷⁷Lu-PP-F11N shows a promising biodistribution. The dose-limiting organ is most likely the stomach. Further clinical studies are necessary to evaluate the maximum tolerated dose and the efficacy of ¹⁷⁷Lu-PP-F11N.

100 项与 177Lu-PP-F11N 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
甲状腺髓样癌	临床1期	-	Universitätsspital Basel	-
甲状腺癌转移	临床前	瑞士	Universitätsspital Basel	2018-12-13

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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


SNMMI2019	N/A	甲状腺髓样癌	-	177Lu-PP-F11N with Physiogel	繭顧膚製糧醖顧淵築襯(窪製窪鏇壓窪膚憲艱窪) = Adverse reactions (mainly hypotension, flushing and hypokalemia) were self-limiting and not higher than grade 1 衊遞鹹製製艱築鹽鑰糧 (鑰簾衊簾醖餘製觸艱顧 ) 更多	-	2019-05-21
				177Lu-PP-F11N without Physiogel