Clinical trial NCT05233098: TheraSphere Post-Approval Study to Calculate the Radiation-absorbed Dose of Tc-99m MAA.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-02-10
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delivered Activity of Tc-99m MAA (MBq) for Whole Body
timeFrame: Immediately following
measure: Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
timeFrame: Immediately following
measure: Delivered Activity of Tc-99m MAA (MBq) for Whole Body
timeFrame: 4 hours +/- 2 hours
measure: Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs.
timeFrame: 4 hours +/- 2 hours
measure: Delivered Activity of Tc-99m MAA (MBq) for Whole Body.
timeFrame: 18-24 hours
measure: Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
timeFrame: 18-24 hours
measure: Absorbed Dose of Tc-99m MAA (mGy) for Whole Body.
timeFrame: Overall
measure: Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs
timeFrame: Overall
measure: Effective Dose of Tc-99m MAA (mSv) Whole Body
timeFrame: Overall
measure: Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body
timeFrame: Overall
measure: Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs
timeFrame: Overall
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Riad Salem, MD
role: PRINCIPAL_INVESTIGATOR
References: