The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled.
The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled. Primary endpoint : Local response (evaluated with CT and MRI at 4 to 6 weeks post each procedure and at 6 months according to mRECIST) in patients with intermediate-stage HCC following chemoembolisation with radiopaque bead. Secondary endpoints include: 1) Better definition of end point of embolization for drug eluting beads : Ability to achieve near-stasis during chemoembolisation procedure in the tumour feeding vessels using intra-procedural imaging feedback from the radiopaque bead (early visualization of non target embolization 2) Total dose needed for tumor devascularization 3)Distribution of radiopaque beads and correlation with necrosis and adverse events
Study Type
OBSERVATIONAL
Enrollment
50
correlation of necrosis with the deposition of beads
Evgenidion Hospital
Athens, Attica, Greece
CORRELATION OF LUMI DISTRIBUTION WITH NECROSIS
Local response following chemoembolisation
Time frame: 12 months
Definition of end point of embolization for drug eluting beads
optimization of embolization
Time frame: 12 months
Total dose needed for tumor devascularization
dose required for tumor devascularization
Time frame: 12 months
Distribution of radiopaque beads and correlation with necrosis
correlation between imaging and tumor necrosis
Time frame: 12 months
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