Clinical trial · Interventional
Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE
Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE: a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepato Cellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media | Drug | — | UNRESOLVED |
| Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Iodinate contrast
- description
- Doxorubicin solution reconstituted in 5 mL iso-osmolar ionic iodinated contrast media
- interventionNames
- Drug: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media
- type
- ACTIVE_COMPARATOR
- label
- Normal saline
- description
- Doxorubicin solution reconstituted in 5 mL normal saline
- interventionNames
- Drug: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline
Primary outcomes (4)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
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