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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-04

Study Completion Date

2023-06-14

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).

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinical Cohort

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.

Technetium-99m macroaggregated albumin (Tc-99m MAA)

Intervention Type DEVICE

Patients who are being evaluated for TheraSphere administration.

Interventions

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Technetium-99m macroaggregated albumin (Tc-99m MAA)

Patients who are being evaluated for TheraSphere administration.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No