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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2019-10-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Drug Eluting TACE in Primary HCC

NCT04048317

Hepatic Cell Carcinoma

UNKNOWN EARLY_PHASE1

Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer

NCT02753881

Liver Cancer

COMPLETED PHASE1

Lipiodol-TACE With Idarubicin Based On a Specific Emulsion Ratio for Hepatocellular Carcinoma

NCT05631613

Hepatocellular Carcinoma

UNKNOWN

TACE With Drug Eluting Beads Loaded With Doxorubicin in Liver Metastases From Melanoma Patients

NCT01409733

Stage IV Melanoma Patients With Unresectable Liver Metastases

UNKNOWN PHASE1/PHASE2

Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)

NCT01116635

Hepatocellular Carcinoma

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepato Cellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Iodinate contrast

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Normal saline

Doxorubicin solution reconstituted in 5 mL normal saline

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No