Hepato Cellular Carcinoma
Conditions
Keywords
Conventional transarterial chemoembolization (c-TACE), Doxorubicin, Kinetics of distribution
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.
Interventions
DRUGSuper selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media
Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media
DRUGSuper selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline
Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | T0: 1 min before cTACE drug injection star | Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 min before cTACE drug injection starts, | Continuous image recording (videos) through the course of the cTACE drug injection, from 1 minute before drug injection starts to the time when cTACE drug injection is completed |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORIuian 03 69 55 15 27, MD
University Hospital, Strasbourg, France
Outcome results
None listed