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).
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 Type
OBSERVATIONAL
Enrollment
6
Patients who are being evaluated for TheraSphere administration.
Northwestern University
Chicago, Illinois, United States
Delivered Activity of Tc-99m MAA (MBq) for Whole Body
To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body.
Time frame: Immediately following
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
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.
Time frame: Immediately following
Delivered Activity of Tc-99m MAA (MBq) for Whole Body
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body.
Time frame: 4 hours +/- 2 hours
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs.
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.
Time frame: 4 hours +/- 2 hours
Delivered Activity of Tc-99m MAA (MBq) for Whole Body.
To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body following injection.
Time frame: 18-24 hours
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
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.
Time frame: 18-24 hours
Absorbed Dose of Tc-99m MAA (mGy) for Whole Body.
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to the whole body.
Time frame: Overall
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Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to Non-Liver Critical Organs.
Time frame: Overall
Effective Dose of Tc-99m MAA (mSv) Whole Body
To provide imaging data calculating radiation-effective does of Tc-99m MAA to Non-Liver Critical Organs.
Time frame: Overall
Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body
To provide data calculating radiation-effective dose of Tc-99m MAA to Whole Body.
Time frame: Overall
Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs
To provide imaging data calculating radiation-equivalent dose of Tc-99m MAA to Non-Liver Critical Organs.
Time frame: Overall