188Re-SSS Lipiodol(188Re-SSS Lipiodol) - 在研适应症：不可切除的肝细胞癌_专利_临床

概要

基本信息

药物类型

小分子偶联药物、治疗用放射药物

别名-

靶点-

作用方式-

作用机制

电离辐射发射源

治疗领域

肿瘤消化系统疾病

在研适应症

不可切除的肝细胞癌

非在研适应症-

原研机构

Center Eugene Marquis

在研机构

Center Eugene Marquis

非在研机构-

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

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关联

2

项与 188Re-SSS Lipiodol 相关的临床试验

CTIS2023-503341-60-00

/ Recruiting临床2期IIT

Efficacy evaluation of 188Re-SSS lipiodol Selective Internal Radiation Therapy of non operable hepatocellular carcinoma patients, a phase II study - 2017-1-14-010

开始日期2024-02-14

申办/合作机构-

NCT01126463

/ Completed临床1期IIT

Phase 1 Study of Hepatic Intra-Arterial Administration of 188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas

This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the radioprotection constraints and hence the duration of the hospitalisation in a protected room from 8 to 1 day.

开始日期2010-05-26

申办/合作机构

Center Eugene Marquis

[+1]

100 项与 188Re-SSS Lipiodol 相关的临床结果

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100 项与 188Re-SSS Lipiodol 相关的转化医学

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100 项与 188Re-SSS Lipiodol 相关的专利（医药）

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11

项与 188Re-SSS Lipiodol 相关的文献（医药）

2023-04-11·Cancers

¹⁸⁸Re-SSS Lipiodol Radioembolization in HCC Patients: Results of a Phase 1 Trial (Lip-Re-01 Study).

Article

作者: Ardisson, Valérie ; Laffont, Sophie ; Palard, Xavier ; Garin, Etienne ; Bellissant, Eric ; Le Sourd, Samuel ; Campillo-Gimenez, Boris ; Bouvry, Christelle ; Edeline, Julien ; Lepareur, Nicolas ; Rolland, Yan

BACKGROUNDDespite the wide development of ⁹⁰Y-loaded microspheres, ¹⁸⁸Re-labeled lipiodol is still being used for radioembolization of hepatocellular carcinoma (HCC). However, the use of this latter compound is limited by in vivo instability. This study sought to evaluate the safety, bio-distribution, and response to ¹⁸⁸Re-SSS lipiodol, a new and more stable compound.METHODLip-Re-01 was an activity-escalation Phase 1 study involving HCC patients progressing after sorafenib. The primary endpoint was safety based on Common Terminology Criteria for Adverse Events (AEs) of Grade ≥3 within 2 months. Secondary endpoints included bio-distribution assessed by scintigraphy quantification from 1 to 72 h, tumor to non-tumor uptake ratio (T/NT), as well as blood, urine and feces collection over 72 h, dosimetry, and response evaluation (mRECIST).RESULTSOverall, 14 heavily pre-treated HCC patients were treated using a whole liver approach. The mean injected activity was 1.5 ± 0.4 GBq for activity Level 1 (n = 6), 3.6 ± 0.3 GBq for Level 2 (n = 6), and 5.0 ± 0.4 GBq for Level 3 (n = 2). Safety was acceptable with only 1/6 of Level 1 and 1/6 of Level 2 patients experiencing limiting toxicity (one liver failure; one lung disease). The study was prematurely discontinued unrelated to clinical outcomes. Uptake occurred in the tumor, liver, and lungs, and only sometimes in the bladder. The T/NT ratio was high with a mean of 24.9 ± 23.4. Cumulative urinary elimination and fecal eliminations at 72 h were very low, 4.8 ± 3.2% and 0.7 ± 0.8%, respectively. Partial response occurred in 21% of patients (0% in the first activity level; 37.5% in the others).CONCLUSIONThe high in vivo stability of ¹⁸⁸Re-SSS lipiodol was confirmed, resulting in encouraging responses for a Phase 1 study. As the 3.6 GBq activity proved to be safe, it will be used in a future Phase 2 study.

2019-07-01·European Journal of Nuclear Medicine and Molecular Imaging

Preliminary results of the Phase 1 Lip-Re I clinical trial: biodistribution and dosimetry assessments in hepatocellular carcinoma patients treated with 188Re-SSS Lipiodol radioembolization

Article

作者: Le Sourd, Samuel ; Edeline, Julien ; Palard, Xavier ; Delaunay, Kostas ; Ardisson, Valérie ; Bellissant, Éric ; Lepareur, Nicolas ; Bouvry, Christelle ; Rolland, Yan ; Garin, Etienne ; Noiret, Nicolas ; Pracht, Marc ; Laffont, Sophie

PURPOSEThis study sought to provide preliminary results on the biodistribution and dosimetry following intra-arterial liver injection of ¹⁸⁸Re-SSS Lipiodol on hepatocellular carcinoma patients included in the Phase I Lip-Re 1 study.METHODSResults of the first six patients included are reported. Analysis of the ¹⁸⁸Re-SSS Lipiodol biodistribution was based on planar scintigraphic and tomoscintigraphic (SPECT) studies performed at 1, 6, 24, 48, and 72 h post-administration. Quantification in blood, urine, and stool samples was performed. Determination of the tumour to non-tumour uptake ratio (T/NT) was calculated. Absorbed doses to target organs and tumours were evaluated using the MIRD formalism.RESULTSThe mean injected activity of ¹⁸⁸Re-SSS Lipiodol was 1645 ± 361 MBq. Uptakes were seen in the liver (tumour and healthy liver) and the lungs only. All these uptakes were stable over time. A mean 1.4 ± 0.7% of ¹⁸⁸Re-SSS Lipiodol administered was detected in serum samples at 6 h, declining rapidly thereafter. On average, 1.5 ± 1.6% of administered activity was eliminated in urine and feces over 72 h. Overall, 90.7 ± 1.6% of detected activity on SPECT studies was found in the liver (74.9 ± 1.8% in tumours and 19.1 ± 1.7% in the healthy liver) and 9.3 ± 1.6% in the lungs (5.7 ± 1.1% in right and 3.7 ± 0.5% in left lungs). Mean doses absorbed were 7.9 ± 3.7Gy to the whole liver, 42.7 ± 34.0Gy to the tumours, 10.2 ± 3.7Gy to the healthy liver, and 1.5 ± 1.2Gy to the lungs. Four patients had stable disease on CT scans at 2 months. The first patient with rapidly progressive disease died at 1 month, most probably of massive tumour progression. Due to this early death and using a conservative approach, the trial independent evaluation committee decided to consider this event as a treatment-related toxicity.CONCLUSION¹⁸⁸Re-SSS Lipiodol has a favorable biodistribution profile concerning radioembolization, with the highest in-vivo stability among all radiolabeled Lipiodol compounds reported to date. These preliminary results must be further confirmed while completing this Phase I Lip Re1 study.

2012-02-01·Nuclear Medicine Communications4区 · 医学

Reduction of β-radiation exposure during preparation of 188Re-labelled Lipiodol for hepatocellular carcinoma treatment

4区 · 医学

Article

作者: Valérie Ardisson ; Sophie Laffont ; Nicolas Noiret ; Etienne Garin ; Nicolas Lepareur

Rhenium-188 (188Re) is of widespread interest for treating various diseases because of its attractive physical and chemical properties. The routine preparation of therapeutic doses of 188Re-labelled tracers can result in significant radiation exposure to the operator. We studied the impact of automating the preparation of 188Re-Lipiodol on the radiochemist's exposure, as well as the importance of the model of syringe shielding. To monitor radiation exposure continuously readable electronic personal dosimeters were used. Thermoluminescence dosimeters were fixed to the probable most exposed fingers of the radiochemist during preparation of the radiotracer and during the syringing. Dose rates were measured using a Babyline. Automation of the synthesis reduced personal dose equivalents from 2.60±4.35 to 1.61±1.20 µSv/GBq [Hp(10)] and from 38.37±55.28 to 21.84±16.14 µSv/GBq [Hp(0.07)]. Dose to the extremities was also reduced (-80% for the right hand; -58% for the left one). The Lemer-Pax PSWG syringe shield led to a slightly lower dose to the hands compared with the Medisystem (1.1±0.27 vs. 1.34±0.6 mSv/GBq for the right finger). Automation of the synthesis leads to a significant decrease in radiation exposure to the operator. The Lemer-Pax PSWG syringe shield provides better hand protection than the smaller Medisystem Mediclic.

100 项与 188Re-SSS Lipiodol 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
不可切除的肝细胞癌	临床2期	法国	Center Eugene Marquis	2024-02-14

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临床结果

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


Lip-Re 1 (SNMMI2022)	临床1期	肝细胞癌 sorafenib	14	188Re-SSS lipiodol	(艱艱簾窪鑰繭餘鹹範糧) = 淵願鑰構鏇鬱觸願願窪觸憲壓衊築鹹鑰願夢鬱 (憲選膚繭簾襯齋衊衊夢 ) 更多	积极	2022-08-08
NCT01126463 (Lip Re 1, EANM2019)	临床1期	肝细胞癌	6	188 Re-SSS Lipiodol	鹽鑰襯廠繭憲簾簾遞齋(鏇壓鹹襯遞獵鹹積選淵) = 膚膚廠衊夢艱鏇鹹夢繭襯積廠蓋網窪鹽選築顧 (膚鏇憲糧願觸廠夢繭構 ) 更多	积极	2019-09-18
NCT01126463 (Lip Re 1, EANM2019)	临床1期	肝细胞癌	6	188 Re SSS Lipiodol (Reference quantification)	繭簾選餘齋鏇廠顧憲廠(廠觸構積淵廠鑰夢衊衊) = 淵淵憲積構醖鬱膚糧製壓夢鹽壓醖顧鬱窪憲鬱 (簾鏇鹽醖膚窪積壓醖遞 ) 更多	积极	2019-09-18
NCT01126463 (Lip Re I, EANM2018)	临床1期	肝细胞癌	6	188 Re SSS Lipiodol (Scatter fraction 0.5)	遞選鏇願獵衊壓齋夢製(製簾衊鑰夢製選鬱蓋遞) = 蓋鹽膚鏇齋淵築繭願鬱鹹鑰願觸壓醖壓鹽糧糧 (顧選築窪齋觸夢鹹顧憲, 1.42) 更多	积极	2018-09-18
NCT01126463 (Lip Re I, EANM2018)	临床1期	肝细胞癌	6	188 Re SSS Lipiodol (Scatter fraction 1)	遞選鏇願獵衊壓齋夢製(製簾衊鑰夢製選鬱蓋遞) = 製積繭夢夢構構積顧壓鹹鑰願觸壓醖壓鹽糧糧 (顧選築窪齋觸夢鹹顧憲, 2.01) 更多	积极	2018-09-18
NCT01126463 (Lip Re 1, SNMMI2018)	临床1期	肝细胞癌	6	188Re-SSS Lipiodol	蓋觸糧壓顧齋醖鹹淵襯(觸範遞廠廠範蓋艱窪顧) = one patient had a biological partial response 願繭積積鬱醖範蓋築鑰 (艱膚繭艱築艱廠鏇觸繭 ) 更多	积极	2018-05-23