Status:
COMPLETED
TheraSphere Post-Approval Study to Calculate the Radiation-absorbed Dose of Tc-99m MAA.
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
21+ years
Brief Summary
The TheraSphere Post-Approval Study is a post-market, prospective, single-arm, open-label, observational study to support the use of TheraSphere for the treatment of hepatocellular carcinoma (HCC).
Detailed Description
Every patient being treated with TheraSphere needs to have a screening procedure with the administration of a radioactive product named Tc-99m MAA (called pre-treatment mapping). This screening proced...
Eligibility Criteria
Inclusion
- Patients 21 years and older
- Written informed consent
- Patients who receive Tc-99m MAA while being evaluated for TheraSphere treatment.
Exclusion
- Patients who are contraindicated for TheraSphere treatment.
- Patients who are contraindicated for Tc-99m MAA per the applicable Package Insert.
- Patients who do not receive Tc-99m MAA during pre-treatment Y-90 mapping
Key Trial Info
Start Date :
April 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 14 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05233098
Start Date
April 4 2022
End Date
June 14 2023
Last Update
March 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern University
Chicago, Illinois, United States, 60611