TheraSphere Post-Approval Study to Calculate the Radiation-absorbed Dose of Tc-99m MAA.

Boston Scientific

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Device: Technetium-99m macroaggregated albumin (Tc-99m MAA)

Study type: Observational

Funder types: Industry

Identifiers

NCT05233098

S2494

Details and patient eligibility

About

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).

Full 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 procedure aims to determine if the patient can be treated with TheraSphere. The purpose of this study is to better understand the dose of radiation that is absorbed by the body and the risk of Tc-99m MAA to the whole body and other organs around the liver. The study will determine the amount of Tc-99m MAA that stays in the body and organs up to 24 hours after the administration.

Enrollment: 6 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients 21 years and older
2. Written informed consent
3. Patients who receive Tc-99m MAA while being evaluated for TheraSphere treatment.

Exclusion criteria

1. Patients who are contraindicated for TheraSphere treatment.
2. Patients who are contraindicated for Tc-99m MAA per the applicable Package Insert.
3. Patients who do not receive Tc-99m MAA during pre-treatment Y-90 mapping

Trial design

6 participants in 1 patient group

Clinical Cohort

Description:

Patients enrolled in the study will have 3 imaging scans taken after Tc-99m MAA injection. The final scan will occur between 18 and 24 hours after Tc-99m MAA injection.

Treatment:

Device: Technetium-99m macroaggregated albumin (Tc-99m MAA)