Clinical trial · Interventional
188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas
Phase 1 Study of Hepatic Intra-Arterial Administration of 188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas
NCT01126463CI-TRIAL-00053015LIP-RE-IcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinomas | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 188Re-SSS Lipiodol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rhenium Lipiodol
- description
- Hepatic Intra-Arterial Administration of radio-active lipiodol.
- interventionNames
- Drug: 188Re-SSS Lipiodol
Primary outcomes (1)
- measure
- Maximal tolerated dose
- timeFrame
- Injection each week during 4 weeks and at month 2
- description
- Toxicity CTC grade ≥ 3 with CTCAE version 4.
Secondary outcomes (1)
- measure
- Bio-availability
- timeFrame
- 1, 6, 24 et 48 hours after treatment injection
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult over 18, * WHO performance status ≤ 2, * Hepatocellular carcinoma histologically or cytologically proven, or association of liver tumor with chronic hepatopathy and AFP \> 400 ng/ml, or tumorous hepatic formation considered as hypervascularised by at least 2 methods of imaging in cirrhotic patient, Non operable, non resectable, non transplantable, non accessible to percutaneous treatment tumor, * Measurable tumor, uni- or multinodular, taking up less than 50% of hepatic volume, * Stage A to C of the BCLC classification (or stage 0 to 4 of the CLIP) with: * No thrombosis of the portal vein, therapeutic escape or intolerance causing the end of the treatment or contraindication to sorafenib * If thrombosis of the portal vein, therapeutic escape to Lipiocis, * Possibility of treatment by intra-arterial radiotherapy over a decision of a Multidisciplinary Committee, * Written informed consent Exclusion Criteria: * Patient with a stage ≥ 3 toxicity of the CTCAE version 4 * Stage D of the classification BCLC * Acute impairment of hepatic functions (Child-Pugh B9 or C) * Grade III Hepatocarcinoma of the Okuda classification * Encephalopathy with troubles even moderated of cognitive functions * Advanced chronic respiratory insufficiency * Creatinine clearance \< 55 ml/min, polynuclear neutrophils \< 1500 G/L, platelets \< 50 G/L, prothrombin \< 40% (INR \> 2,3) * Contraindication to the intra-arterial administration * Patients who can't be followed up for psychological or geographic reasons * Patients dependant on another person for daily care * Urinary incontinence * Progressive cancer * Pregnant or breastfeeding woman, or not using adequate effective contraception method
References
Publications (1)
- BACKGROUNDGarin E, Rakotonirina H, Lejeune F, Denizot B, Roux J, Noiret N, Mesbah H, Herry JY, Bourguet P, Lejeune JJ. Effect of a 188 Re-SSS lipiodol/131I-lipiodol mixture, 188 Re-SSS lipiodol alone or 131I-lipiodol alone on the survival of rats with hepatocellular carcinoma. Nucl Med Commun. 2006 Apr;27(4):363-9. doi: 10.1097/00006231-200604000-00008. PMID 16531923