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

NCT05233098 | Completed Results FDA Device

• 1 other identifier: S2494
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hepatocellular Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Overall

• 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.

  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.

  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.

  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.

  Overall

Study Arms (1)

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)

Interventions

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

Patients who are being evaluated for TheraSphere administration.

Clinical Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients 21 years and older
• Written informed consent
• Patients who receive Tc-99m MAA while being evaluated for TheraSphere treatment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Jessie Stockwell, Sr. Clinical Trial Specialist
• Organization: Boston Scientific

jessie.stockwell@bsci.com

6126181136

Study Officials

• Riad Salem, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 10, 2022
• Study Start: April 4, 2022
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)