DC Bead LUMI (TM) Loaded With Doxorubicin for Intermediate Hepatocellular Carcinoma (HCC)

Hepatocellular Cancer Clinical Trial

Official title: Correlation of Necrosis With DC Bead LUMI (TM) Distribution

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Chemoembolization
• Hepatocellular Cancer
• Liver Neoplasms

• NCT number: NCT03474354
• Study type: Observational
• Source: University of Athens
• Status: Completed
• Start date: May 2, 2018
• Completion date: January 5, 2022