Study to Calculate the Radiation-Absorbed Dose of Technetium-99m Macroaggregated Albumin (99mTc-MAA) to the Whole Body and Non-Liver Critical Organs
Overview
- Phase
- Phase 4
- Intervention
- 99mTc-Macro Albumin Aggregate
- Conditions
- Carcinoma
- Sponsor
- Sirtex Medical
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Mean Absorbed Dose (Gy) for the Whole Body
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing, able, and mentally competent to provide written informed consent
- •Age 18 or older at the time of consent
- •Patients who are being evaluated for SIR-Spheres treatment eligibility
Exclusion Criteria
- •Patients who are contraindicated for SIR-Spheres treatment
- •Patients who are contraindicated for 99mTc-MAA per the manufacturer's package insert
Arms & Interventions
99mTc-MAA Injection
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.
Intervention: 99mTc-Macro Albumin Aggregate
Outcomes
Primary Outcomes
Mean Absorbed Dose (Gy) for the Whole Body
Time Frame: 18-24 hours
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Time Frame: 18-24 hours
Mean Activity (Bq) for the Whole Body
Time Frame: 18-24 hours
Mean Activity (Bq) for Critical Non-liver Organs
Time Frame: 18-24 hours
Effective Dose (Gy) for the Whole Body
Time Frame: 18-24 hours