Study to Calculate the Radiation-Absorbed Dose of Technetium-99m Macroaggregated Albumin (99mTc-MAA) to the Whole Body and Non-Liver Critical Organs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sirtex Medical
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Mean Absorbed Dose (Gy) for the Whole Body
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
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
Secondary Outcomes
No secondary outcomes reported