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

Phase 4

Completed

• Conditions: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasm
• Interventions: Drug: 99mTc-Macro Albumin Aggregate

• Registration Number: NCT05848947
• Lead Sponsor: Sirtex Medical

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-21
• Study Start: 2023-04-25
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-08
• Primary Completion: 2023-07-05
• Study Completion: 2023-07-05
• Status Verified: 2025-01
• Results First Submitted: 2025-01-08
• Results First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Results First Posted: 2025-01-29
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Willing, able, and mentally competent to provide written informed consent
2. Age 18 or older at the time of consent
3. Patients who are being evaluated for SIR-Spheres treatment eligibility

Exclusion Criteria

1. Patients who are contraindicated for SIR-Spheres treatment
2. Patients who are contraindicated for 99mTc-MAA per the manufacturer's package insert

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
99mTc-MAA Injection	99mTc-Macro Albumin Aggregate	Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.

Primary Outcome Measures

Name	Time	Method
Mean Absorbed Dose (Gy) for the Whole Body	18-24 hours
Mean Absorbed Dose (Gy) for Critical Non-liver Organs	18-24 hours
Mean Activity (Bq) for the Whole Body	18-24 hours
Mean Activity (Bq) for Critical Non-liver Organs	18-24 hours
Effective Dose (Gy) for the Whole Body	18-24 hours

Trial Locations

Locations (1)

Inland Imaging; 🇺🇸 Spokane, Washington, United States