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NCT Number: NCT03706157

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

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.

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Key information

Conditions

Hepato Cellular Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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

    Time frame: 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.

  2. 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

    Time frame: T1 : 2 min after cTACE drug injection started

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

  3. 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

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

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

  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

    Time frame: T3: 1 min after cTACE drug injection is completed

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

Secondary outcomes

  1. 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

    Time frame: 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

  2. 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

    Time frame: 2 min after cTACE drug injection started,

    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

  3. 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

    Time frame: 1 second after half of cTACE drug has been injected,

    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

  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

    Time frame: 1 min after cTACE drug injection is completed,

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE: a Pilot Study

Acronym: CineDoxo

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2018
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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