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

Hepatocellular Carcinoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05233098
• Other study ID #: S2494
• Status: Completed
• Start date: February 4, 2023
• Est. completion date: June 14, 2023

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Hepatocellular Carcinoma

Intervention

Device:
• Technetium-99m macroaggregated albumin (Tc-99m MAA)
Patients who are being evaluated for TheraSphere administration.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean absorbed dose (Gy) for the whole body		24 hours
Primary	Mean absorbed dose (Gy) for critical non-liver organs		24 hours
Primary	Mean activity (Bq) for the whole body		24 hours
Primary	Mean activity (Bq) for critical non-liver organs		24 hours
Primary	Effective dose (Gy) for the whole body		24 hours