Delving into the Latest Updates on 188Re-SSS Lipiodol with Synapse

Overview

Basic Info

Drug Type

Small molecule-drug conjugates, Therapeutic radiopharmaceuticals

Synonyms-

Target-

Mechanism

Ionising radiation emitters

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication

Unresectable Hepatocellular Carcinoma

Inactive Indication-

Originator Organization

Center Eugene Marquis

Active Organization

Center Eugene Marquis

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

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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.

Start Date26 May 2010

Sponsor / Collaborator

Center Eugene Marquis

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100 Clinical Results associated with 188Re-SSS Lipiodol

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100 Translational Medicine associated with 188Re-SSS Lipiodol

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100 Patents (Medical) associated with 188Re-SSS Lipiodol

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24

Literatures (Medical) associated with 188Re-SSS Lipiodol

01 Jun 2024·Nuclear Medicine Communications

Re-188 lipiodol in hepatocellular carcinoma with portal vein thrombosis: a pilot study using novel chelating agent N-DEDC and its comparison with (A)HDD

Article

Author: Gupta, Priyanka ; Datta Gupta, Shreya Shalimar ; Shamim, Shamim A. ; Bal, Chandrasekhar ; Chirayil, Viju ; Dash, Ashutosh ; Mallia, Madhav B. ; Gamanagatti, Shivanand ; Khan, Maroof A.

ObjectiveHepatocellular carcinoma (HCC) with portal vein thrombosis (PVT) have limited therapeutic options, Re-188 lipiodol transarterial therapy being one of them. We aimed to assess the safety and efficacy of Re-188 lipiodol exclusively in HCC with PVT as well as to compare two chelating agents for the synthesis of Re-188 lipiodol: novel bis-(diethyldithiocarbamato) nitrido (N-DEDC) with existing acetylated 4-hexadecyl 1-2,9,9-tetramethyl-4,7-diaza-1,10-decanethiol [(A)HDD].MethodsPatients with radiological diagnosis of HCC with PVT having Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and Child Pugh score (PS) A or B were recruited. Patients received an empirical dose of transarterial Re-188 lipiodol, labelled with (A)HDD or N-DEDC. Radiological response on MRI (modified response evaluation criteria in solid tumors), biochemical response with serum alpha fetoprotein and clinical response with ECOG PS was assessed at three months and survival was estimated at the end of the study.ResultsFifteen therapies were performed in 14 patients with a median age of 62 years (range: 41–70 years). Eight therapies were with Re-188 (A)HDD lipiodol and seven with Re-188 N-DEDC lipiodol. Overall mean injected dose was 2.6 ± 0.37 GBq. Radiological objective response rate was 31% and disease control rate was 85%. Mean overall survival was 14.21 months and mean progression free survival was 10.23 months. Percentage survival assessed at 3, 6 and 9 months was 93%, 64% and 57%, respectively. Safety parameters, response and survival outcome were comparable for (A)HDD and N-DEDC groups.ConclusionTransarterial Re-188 lipiodol in HCC with PVT is safe and effective in disease control as well as improving survival outcome. Additionally, cost-effective and high-yielding novel agent N-DEDC appears to be a comparable alternative to (A)HDD for the same.

11 Apr 2023·Cancers

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

Article

Author: 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.

01 Feb 2022·Cancer Biotherapy and RadiopharmaceuticalsQ4 · MEDICINE

Preparation of Rhenium-188-Lipiodol Using Freeze-Dried Kits for Transarterial Radioembolization: An Overview and Experience in a Hospital Radiopharmacy

Q4 · MEDICINE

Article

Author: Pandiyan, Arun ; Radhakrishnan, Edathurutykalarickal Ramakurup ; Chirayil, Viju ; Shinto, Ajit ; Mallia, Madhava B. ; Subramanian, Suresh ; Kamaleshwaran, Koramadai Karuppusamy

Background: Rhenium-188(¹⁸⁸Re)-lipiodol is a clinically effective, economically viable radiopharmaceutical for Selective Internal Radiation Therapy of liver cancer. Present study evaluates the performance of three freeze-dried kits with respect to the radiochemistry, quality control, and overall "ease of preparation" aspects in a hospital radiopharmacy. Materials and Methods: Freeze-dried kits of acetylated 4-hexadecyl-4,7-diaza-1,10-decanedithiol (AHDD), super six sulfur (SSS), and diethyl dithiocarbamate (DEDC), obtained commercially or received as gift, were used for the preparation of ¹⁸⁸Re-lipiodol using freshly eluted ¹⁸⁸Re-sodium perrhenate from commercial Tungsten-188/¹⁸⁸Re generator following recommended procedures. Results: The overall yield of ¹⁸⁸Re-lipiodol prepared using AHDD Kit, SSS Kit, and DEDC Kit was 74.82% ± 3.3%, 87.55% ± 4.8%, and 76.38% ± 4.6%, respectively. Observed radiochemical purity (RCP) of ¹⁸⁸Re-lipiodol prepared using these kits was 88.65% ± 2.8%, 92.92% ± 3.0%, and 91.38% ± 3.0%, respectively. Using a modified version of the DEDC Kits, overall yield of 87.17% ± 2.7% and RCP of 95.43% ± 2.3% could be achieved. Conclusions: While all three freeze-dried kits can be used for the preparation of ¹⁸⁸Re-lipiodol in >70% overall yield, the modified version of DEDC Kits has some advantages in terms of preparation time and volume of Rhenium-188 activity that can be added to the kit vial. The latter feature of the DEDC Kit is particularly useful for patient dose preparation with ¹⁸⁸Re activity of low radioactive concentration.

100 Deals associated with 188Re-SSS Lipiodol

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Unresectable Hepatocellular Carcinoma	Phase 2	FR	Center Eugene Marquis	14 Feb 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Lip-Re 1 (SNMMI2022)	Phase 1	Hepatocellular Carcinoma sorafenib	14	188Re-SSS lipiodol	(xtojxxoswj) = rwsqbsylem guspafhixm (lxbigyvyfj ) View more	Positive	08 Aug 2022
NCT01126463 (Lip Re 1, EANM2019)	Phase 1	Hepatocellular Carcinoma	6	188 Re-SSS Lipiodol	rtwalfctun(wgattbfjtw) = ynmtpdvnws erxmjdshwl (ooueucuzha ) View more	Positive	18 Sep 2019
NCT01126463 (Lip Re 1, EANM2019)	Phase 1	Hepatocellular Carcinoma	6	188 Re SSS Lipiodol (Reference quantification)	foxhfxgxnr(vbsnmypxvq) = ozeeyeoqqe xyrblmkaou (rrsbhqxzue ) View more	Positive	18 Sep 2019
NCT01126463 (Lip Re I, EANM2018)	Phase 1	Hepatocellular Carcinoma	6	188 Re SSS Lipiodol (Scatter fraction 0.5)	meczkntecv(zptaszmrwq) = dzquyviwzq oynpnqitsh (agmhfrakwj, 1.42) View more	Positive	18 Sep 2018
NCT01126463 (Lip Re I, EANM2018)	Phase 1	Hepatocellular Carcinoma	6	188 Re SSS Lipiodol (Scatter fraction 1)	meczkntecv(zptaszmrwq) = onlacpmbyr oynpnqitsh (agmhfrakwj, 2.01) View more	Positive	18 Sep 2018
NCT01126463 (Lip Re 1, SNMMI2018)	Phase 1	Hepatocellular Carcinoma	6	188Re-SSS Lipiodol	bjnyqjhblm(dqaepukgka) = one patient had a biological partial response koajyscgbi (nlgkbatnoz ) View more	Positive	23 May 2018