Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE

NCT03706157 | Completed Phase 4 DMC

• 1 other identifier: 7040
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepato Cellular Carcinoma

Keywords

Conventional transarterial chemoembolization (c-TACE); Doxorubicin; Kinetics of distribution

Outcome Measures

Primary Outcomes (4)

• 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

  Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.

  T0: 1 min before cTACE drug injection star

• 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

  Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.

  T1 : 2 min after cTACE drug injection started

• 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

  Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.

  T2: 1 second after half of cTACE drug has been injected

• 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

  Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.

  T3: 1 min after cTACE drug injection is completed

Secondary Outcomes (4)

• 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,

• 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

  2 min after cTACE drug injection started,

• 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 second after half of cTACE drug has been injected,

• 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 after cTACE drug injection is completed,

Study Arms (2)

Iodinate contrast

ACTIVE COMPARATOR

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

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

Normal saline

ACTIVE COMPARATOR

Doxorubicin solution reconstituted in 5 mL normal saline

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

Interventions

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 iso-osmolar ionic iodinated contrast media

Iodinate contrast

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

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

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• Subject incapacity to understand informed consent

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Location

Study Officials

• Iuian 03 69 55 15 27, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 15, 2018
• Study Start: November 26, 2018
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: July 27, 2020

Record last verified: 2019-08

Locations

FR (1)