NCT05233098

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

TheraSphere Post-approval Study to Calculate the Radiation-absorbed Dose of Technetium-99m Macroaggregated Albumin (Tc-99m MAA) to the Whole Body and Non-liver Critical Organs.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: —

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 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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DEVICE	Technetium-99m macroaggregated albumin (Tc-99m MAA)	Patients who are being evaluated for TheraSphere administration.

Timeline

• Start date: 2022-04-04
• Primary completion: 2023-06-14
• Completion: 2023-06-14
• First posted: 2022-02-10
• Last updated: 2025-03-06
• Results posted: 2025-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study