NCT03474354

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

Correlation of Necrosis With DC Bead LUMI (TM) Distribution

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Malagari Katerina · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: —

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.

Detailed 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

Conditions

• Hepatocellular Cancer
• Chemoembolization

Interventions

Type	Name	Description
DEVICE	chemoembolization	correlation of necrosis with the deposition of beads

Timeline

• Start date: 2018-05-02
• Primary completion: 2022-01-05
• Completion: 2022-01-05
• First posted: 2018-03-22
• Last updated: 2022-01-06

Locations

1 site across 1 country: Greece