Clinical trial NCT03706157: Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE
Official title: Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepato Cellular Carcinoma
Keywords: Conventional transarterial chemoembolization (c-TACE)
Doxorubicin
Kinetics of distribution
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Conventional transarterial chemoembolization with Doxorubicin (c-TACE) is the gold standard treatment for Hepato Cellular Carcinoma (HCC) stage B (BCLC) / stages A and B (Child-Pugh). Clinical recommendations for cTACE indicate that the doxorubicin solution may be reconstituted in either aqueous solution or iso-osmolar ionic iodinated contrast media. There is no consensus on which solvent should be used. Hence, the clinical evaluation of Lipiodol cTACE would benefit from a standardization in the reconstitution of the drug. In this study, the comparison of the kinetics of distribution of the drug within the tumor micro-environment is expected to allow for comparison of drug solvents.

This pilot study aims at evaluating the kinetics of distribution of the drug within the tumor micro-environment, for the two main solvents used in reconstituting the drug, namely normal saline and contrast media. The kinetics of distribution in the tumor will be evaluated primarily through regular biopsy sampling, and secondary with confocal laser endomicroscopy.


Eligibility criteria: Inclusion Criteria:

* Adult (\>18)
* Informed consent
* CHC Child-Pugh stage A or B, BCLC stage B
* Referred for chemoembolization of a non-surgery-candidate CHC
* Blood test results compatible with cTACE (INR ≤ 1,5, ASAT/ALAT\<5N, albumine\>2,5g/dl)

Exclusion Criteria:

* Contraindication to cTACE, angiography, confocal laser endomicroscopy or liver biopsy Hyperthyroidism
* Contraindication to the use of fluorescein, Ariblastine,Lipiodol, Visipaque, Gelita spon, Avitene
* extra hepatic metastasis
* Subcapsular or exophytic tumor impeding direct percutaneous access through healthy liver tissue
* Waiting list for liver transplant
* Complete portal venous thrombosis or flow inversion
* Pregnancy or breast feeding
* Protected major (Guardianship)
* Patient in situation of exclusion (determined by a previous or ongoing study)
* Subject incapacity to understand informed consent

Primary outcomes:
measure: Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
timeFrame: T0: 1 min before cTACE drug injection star
measure: Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
timeFrame: T1 : 2 min after cTACE drug injection started
measure: Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
timeFrame: T2: 1 second after half of cTACE drug has been injected
measure: Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
timeFrame: T3: 1 min after cTACE drug injection is completed
Secondary outcomes:
measure: In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
timeFrame: 1 min before cTACE drug injection starts,
measure: In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
timeFrame: 2 min after cTACE drug injection started,
measure: In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
timeFrame: 1 second after half of cTACE drug has been injected,
measure: In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
timeFrame: 1 min after cTACE drug injection is completed,
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital, Strasbourg, france
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Iuian 03 69 55 15 27, MD
role: PRINCIPAL_INVESTIGATOR
References: