Pilot study on doxorubicin kinetic distribution during arterial chemoembolizatio

Phase 1

• Conditions: hepatocellular carcinoma; MedDRA version: 20.0Level: LLTClassification code 10049010Term: Carcinoma hepatocellularSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002163-26-FR
• Lead Sponsor: Hôpitaux Universitaires de Strasbourg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-04
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

- man and womanof 18 years old or older
- Subject affiliated to social security
- Subject able to understand study scope and rick and give signed informed consent
- histological, cytological or radiological confirmed diagnosis of Hepatocellular carcinoma:
?stade A (patient with transplant pending) and Class B according to BCLC Classification
?Sated A and Baccording to Child-Pugh classification
- chemoembolization indicated for unresecable hepatocellular carcinoma
- biological parmaters allowing chemoembolization procedure (platelet count, bilirubin, INR = 1,5, SGPT/SGOT<5N, albumin>2,5g/dl)
- ECOG performance status = 2
- effective contracpetion during all study
- negative prenancy test for woman child-bearing
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

- Any contra-indication for the procedure of transarterial Chemoembolization, angiography, endomicroscopie, and hepatic biopsy ponction
- blood coagulation parameters abnormalities (TP < 50% and/or platelet <50000 /mm3 and/or ratio TCA <1,5) in spite of hemostatic measure correction
- Any contra-indication for fluorescein, Adriblastin®, Lipiodol®, Visipaque® , Gelita spon®, Avitène
- hyperthyroidism proved undiagnosed
- ilirubine totale > 40 µmol/L
-Créatinin > 2mg/dl
-GFR < 30ml/min/m2
-Neutrophiles < 1500/mm3 ou Plaquettes < 50000/µl
-Hémoglobin < 9g/dl
-white cells < 2500/mm3
- full or flux invesion of portal vein thrombosis
- extrahepatic metastasis
- transplant list inscription
- exophytic or sub capsilaire tumor, with no percutaneous access accross healthy liver with coaxial needle
- exclusion period
- subject unable to understand study information
- Psychiatric disorders and adults under guardianship
- Pregnancy or breastfeeding
- Patients under judicial protection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: intratumoral doxorubicin kinetic distribution assessment with histological analysis as part of lipiodol transarterial chemoembolization, depend on used reconstitution solvent (NaCL 0.9% VS Visipaque);Secondary Objective: 1. Assessment of solvent influence used to Doxorubicine dissolution on intratumoral doxorubicin distribution kinetic with Confocal Lazer Endomicroscopy (CLE)<br><br>2. Safety evaluation;Primary end point(s): Histological analysis : <br>- distribution, frequence, fluorescence intensity frome tumor and adjacent non tumoral hepatic tissu<br>- tissular slide doxorubicin quantification : flourescence produce by tissular compartment and surface;Timepoint(s) of evaluation of this end point: at the end of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): n° 1 : Confocal lazer endomicroscopie :<br>- time of emulsion arrival<br>- time of drug delivery<br>- time of droplet fusion<br><br>n° 2 : collection of study adverse event and serious adverse event;Timepoint(s) of evaluation of this end point: n° 1 : during chemoembolization procédure<br><br>n°2 : during all the study