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Completed

NCT Number: NCT05233098

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

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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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Patients who are being evaluated for TheraSphere administration.

Primary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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