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).

  • STATUS
    Recruiting
  • End date
    May 16, 2023
  • participants needed
    5
  • sponsor
    Boston Scientific Corporation
Updated on 16 October 2022

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 IdentifierNCT05233098
SponsorBoston Scientific Corporation
Last Modified on16 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients 21 years and older
Written informed consent
Patients who receive Tc-99m MAA while being evaluated for TheraSphere treatment as per the approved TheraSphere IFU

Exclusion Criteria

Patients who are contraindicated for TheraSphere treatment per the approved TheraSphere IFU
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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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