MAApping: SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
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
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Patients who are contraindicated for 99mTc-MAA per the manufacturer's package insert
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inland Imaging | Spokane | Washington | United States | 99208 |
Sponsors and Collaborators
- Sirtex Medical
- Bright Research Partners
Investigators
- Principal Investigator: Douglas Murrey, MD, Inland Imaging
Study Documents (Full-Text)
None provided.More Information
Publications
- Gates VL, Singh N, Lewandowski RJ, Spies S, Salem R. Intraarterial Hepatic SPECT/CT Imaging Using 99mTc-Macroaggregated Albumin in Preparation for Radioembolization. J Nucl Med. 2015 Aug;56(8):1157-62. doi: 10.2967/jnumed.114.153346. Epub 2015 Jun 18.
- Kappadath SC, Lopez BP. Organ-level internal dosimetry for intra-hepatic-arterial administration of 99m Tc-macroaggregated albumin. Med Phys. 2022 Aug;49(8):5504-5512. doi: 10.1002/mp.15726. Epub 2022 Jun 6.
- McCollough CH, Bushberg JT, Fletcher JG, Eckel LJ. Answers to Common Questions About the Use and Safety of CT Scans. Mayo Clin Proc. 2015 Oct;90(10):1380-92. doi: 10.1016/j.mayocp.2015.07.011.
- STX2301