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

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: Technetium-99m macroaggregated albumin (Tc-99m MAA)

• Registration Number: NCT05233098
• Lead Sponsor: Boston Scientific Corporation

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 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.

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Study Start: 2022-04-04
• Primary Completion: 2023-06-14
• Study Completion: 2023-06-14
• Status Verified: 2024-07
• Results First Submitted: 2024-07-31
• Results First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Results First Posted: 2025-03-06
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinical Cohort	Technetium-99m macroaggregated albumin (Tc-99m MAA)	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.

Primary Outcome Measures

Name	Time	Method
Delivered Activity of Tc-99m MAA (MBq) for Whole Body	4 hours +/- 2 hours	To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body.
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs	18-24 hours	To provide imaging data to calculate radiation delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs.	4 hours +/- 2 hours	To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Delivered Activity of Tc-99m MAA (MBq) for Whole Body.	18-24 hours	To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body following injection.
Absorbed Dose of Tc-99m MAA (mGy) for Whole Body.	Overall	To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to the whole body.
Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs	Overall	To provide imaging data calculating radiation-equivalent dose of Tc-99m MAA to Non-Liver Critical Organs.
Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs	Overall	To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to Non-Liver Critical Organs.
Effective Dose of Tc-99m MAA (mSv) Whole Body	Overall	To provide imaging data calculating radiation-effective does of Tc-99m MAA to Non-Liver Critical Organs.
Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body	Overall	To provide data calculating radiation-effective dose of Tc-99m MAA to Whole Body.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States