Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE (CineDoxo)

University Hospital, Strasbourg, France

Status and phase: Completed; Phase 4

Conditions: Hepato Cellular Carcinoma

Treatments: Drug: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media; Drug: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03706157

7040

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

10 participants in 2 patient groups

Iodinate contrast

Active Comparator group

Description:

Doxorubicin solution reconstituted in 5 mL iso-osmolar ionic iodinated contrast media

Treatment:

Drug: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media

Normal saline

Active Comparator group

Description:

Doxorubicin solution reconstituted in 5 mL normal saline

Treatment:

Drug: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline