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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: Technetium-99m macroaggregated albumin (Tc-99m MAA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 21 years and older Written informed consent Patients who receive Tc-99m MAA while being evaluated for TheraSphere treatment. Exclusion Criteria: Patients who are contraindicated for TheraSphere treatment. 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical Cohort<br>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. | Device: Technetium-99m macroaggregated albumin (Tc-99m MAA)<br>* Patients who are being evaluated for TheraSphere administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean absorbed dose (Gy) for the whole body |  | 24 hours | 
| Mean absorbed dose (Gy) for critical non-liver organs |  | 24 hours | 
| Mean activity (Bq) for the whole body |  | 24 hours | 
| Mean activity (Bq) for critical non-liver organs |  | 24 hours | 
| Effective dose (Gy) for the whole body |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Liver Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Liver Diseases