Spots Global Cancer Trial Database for BioPearl™ Microspheres Loaded With Doxorubicin: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
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Trial Identification
Brief Title: BioPearl™ Microspheres Loaded With Doxorubicin: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
Official Title: BioPearl™ Microspheres Loaded With Doxorubicin to Treat Patients With Unresectable HCC: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
Study ID: NCT04231929
Conditions
Interventions
Study Description
Brief Summary: The primary objective of the study is to confirm safety and efficacy of BioPearl™ microspheres loaded with doxorubicin in the treatment of patients with unresectable hepatocellular carcinoma (HCC).
Detailed Description: This is a prospective, single arm, multi-centre, post-market study to further assess safety and efficacy in 20 unresectable HCC patients treated with Doxorubicin loaded BioPearl™ microspheres. After the treatment procedure, all patients will undergo clinical follow-up until disease progression and/or next treatment option after which patients will be followed for survival. Patients will be followed up to a maximum of 3 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CUB Hôpital Erasme, Brussels, , Belgium
UZ Gent, Gent, , Belgium
University Hospital Leuven, Leuven, , Belgium
Contact Details
Name: Gontran Verset, MD
Affiliation: CUB Hôpital Erasme
Role: PRINCIPAL_INVESTIGATOR
Name: Geert Maleux, MD
Affiliation: UZ Leuven
Role: PRINCIPAL_INVESTIGATOR
Name: Luc Defreyne, MD
Affiliation: UZ Gent
Role: PRINCIPAL_INVESTIGATOR
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