NCT05848947

SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA

Study to Calculate the Radiation-Absorbed Dose of Technetium-99m Macroaggregated Albumin (99mTc-MAA) to the Whole Body and Non-Liver Critical Organs

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Sirtex Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional clinical trial is to evaluate the dose of radiation of Technetium-99m macroaggregated-albumin (99mTc-MAA) after an intra-arterial injection to the whole body and non-liver critical organs in patients who are undergoing evaluation for SIR-Spheres treatment for hepatocellular carcinoma.

Detailed description

The investigation is a prospective, single center, open label, single-arm study. Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA injection, the final of which will occur between 18 and 24 hours post-injection.

Conditions

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Neoplasm

Interventions

Type	Name	Description
DRUG	99mTc-Macro Albumin Aggregate	Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies.

Timeline

• Start date: 2023-04-25
• Primary completion: 2023-07-05
• Completion: 2023-07-05
• First posted: 2023-05-08
• Last updated: 2025-01-29
• Results posted: 2025-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study