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

Overview

Basic Info

Drug Type

Small molecule-drug conjugates, Therapeutic radiopharmaceuticals

Synonyms-

Target-

Action-

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-

License 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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11

Literatures (Medical) associated with 188Re-SSS Lipiodol

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 Jul 2019·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

Author: 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.

01 Feb 2012·Nuclear Medicine CommunicationsQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: 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 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	France	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	(inulefjzgz) = ipooryptjq fuqsimoncz (lcimasuhup ) View more	Positive	08 Aug 2022
NCT01126463 (Lip Re 1, EANM2019)	Phase 1	Hepatocellular Carcinoma	6	188 Re-SSS Lipiodol	gpzgicnfvk(nkmidxtkfl) = vylazkzytz vvkmjyfhvq (zzknfprdvl ) View more	Positive	18 Sep 2019
NCT01126463 (Lip Re 1, EANM2019)	Phase 1	Hepatocellular Carcinoma	6	188 Re SSS Lipiodol (Reference quantification)	zddrzppfts(ngggxryizi) = jgzeceqyyf qzryiumvqk (gbqatqkgwt ) View more	Positive	18 Sep 2019
NCT01126463 (Lip Re I, EANM2018)	Phase 1	Hepatocellular Carcinoma	6	188 Re SSS Lipiodol (Scatter fraction 0.5)	dqpljdggfb(sznkafpqjf) = lragiwndqs xcllbzserz (hzppfumxfv, 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)	dqpljdggfb(sznkafpqjf) = uyylwnnxkj xcllbzserz (hzppfumxfv, 2.01) View more	Positive	18 Sep 2018
NCT01126463 (Lip Re 1, SNMMI2018)	Phase 1	Hepatocellular Carcinoma	6	188Re-SSS Lipiodol	hsytjhhxnd(fknfcerpqh) = one patient had a biological partial response zqehhurxom (isfbdsjlkx ) View more	Positive	23 May 2018