Phase 4
N=5
SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA
Carcinoma · Carcinoma, Hepatocellular · Liver Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT05848947 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Mean Absorbed Dose (Gy) for the Whole Body — 0.941 mGy
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 99mTc-Macro Albumin Aggregate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sirtex Medical
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Absorbed Dose (Gy) for the Whole Body |
0.941 | — |
| PRIMARY Mean Absorbed Dose (Gy) for Critical Non-liver Organs |
1.415; 4.855; 0.736; 2.073; 1.701; 1.221 | — |
| PRIMARY Mean Activity (Bq) for the Whole Body |
0.150 | — |
| PRIMARY Mean Activity (Bq) for Critical Non-liver Organs |
0.150; 0.148; 0.150; 0.150; 0.150; 0.150 | — |
| PRIMARY Effective Dose (Gy) for the Whole Body |
0.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05848947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.