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 According to the Approved Instructions for Use (IFU).
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- STATUS
- Recruiting
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- End date
- May 16, 2023
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- participants needed
- 5
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- sponsor
- Boston Scientific Corporation
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).
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.
Details
| Condition | Hepatocellular Carcinoma |
|---|---|
| Treatment | Technetium-99m macroaggregated albumin (Tc-99m MAA) |
| Clinical Study Identifier | NCT05233098 |
| Sponsor | Boston Scientific Corporation |
| Last Modified on | 16 October 2022 |
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