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Trial record 4 of 2157 for:    doxorubicin

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

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ClinicalTrials.gov Identifier: NCT03706157
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Hepato Cellular Carcinoma 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 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE: a Pilot Study
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Iodinate contrast
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
Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media

Active Comparator: Normal saline
Doxorubicin solution reconstituted in 5 mL normal saline
Drug: Super 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706157


Contacts
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Contact: Iulian ENESCU, MD 03 69 55 15 27 ext 0033 iulian.enescu@chru-strasbourg.fr

Locations
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France
University Hospital, Strasbourg, france Recruiting
Strasbourg, France, 67000
Contact: Iulian ENESCU, MD    03 69 55 15 27 ext 0033    iulian.enescu@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Iuian 03 69 55 15 27, MD University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03706157     History of Changes
Other Study ID Numbers: 7040
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Conventional transarterial chemoembolization (c-TACE)
Doxorubicin
Kinetics of distribution
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Ethiodized Oil
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action