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

March 3, 2025 updated by: Boston Scientific Corporation

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The intended population for the TheraSphere Post-Approval study is patients with HCC who are undergoing evaluation to assess eligibility for TheraSphere treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Technetium-99m macroaggregated albumin (Tc-99m MAA)
Patients who are being evaluated for TheraSphere administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivered Activity of Tc-99m MAA (MBq) for Whole Body
Time Frame: Immediately following
To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body.
Immediately following
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
Time Frame: Immediately following
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.
Immediately following
Delivered Activity of Tc-99m MAA (MBq) for Whole Body
Time Frame: 4 hours +/- 2 hours
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body.
4 hours +/- 2 hours
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs.
Time Frame: 4 hours +/- 2 hours
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.
4 hours +/- 2 hours
Delivered Activity of Tc-99m MAA (MBq) for Whole Body.
Time Frame: 18-24 hours
To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body following injection.
18-24 hours
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
Time Frame: 18-24 hours
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.
18-24 hours
Absorbed Dose of Tc-99m MAA (mGy) for Whole Body.
Time Frame: Overall
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to the whole body.
Overall
Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs
Time Frame: Overall
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to Non-Liver Critical Organs.
Overall
Effective Dose of Tc-99m MAA (mSv) Whole Body
Time Frame: Overall
To provide imaging data calculating radiation-effective does of Tc-99m MAA to Non-Liver Critical Organs.
Overall
Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body
Time Frame: Overall
To provide data calculating radiation-effective dose of Tc-99m MAA to Whole Body.
Overall
Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs
Time Frame: Overall
To provide imaging data calculating radiation-equivalent dose of Tc-99m MAA to Non-Liver Critical Organs.
Overall

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Riad Salem, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Actual)

June 14, 2023

Study Completion (Actual)

June 14, 2023

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2494

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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