Hepato Cellular Carcinoma Clinical Trial
Official title:
Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE: a Pilot Study
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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