Carcinoma, Hepatocellular Clinical Trial
— MAAppingOfficial title:
Study to Calculate the Radiation-Absorbed Dose of Technetium-99m Macroaggregated Albumin (99mTc-MAA) to the Whole Body and Non-Liver Critical Organs
NCT number | NCT05848947 |
Other study ID # | STX2301 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | April 25, 2023 |
Est. completion date | July 5, 2023 |
Verified date | July 2023 |
Source | Sirtex Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | July 5, 2023 |
Est. primary completion date | July 5, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Inland Imaging | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
Sirtex Medical | Bright Research Partners |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean absorbed dose (Gy) for the whole body | 18-24 hours | ||
Primary | Mean absorbed dose (Gy) for critical non-liver organs | 18-24 hours | ||
Primary | Mean activity (Bq) for the whole body | 18-24 hours | ||
Primary | Mean activity (Bq) for critical non-liver organs | 18-24 hours | ||
Primary | Effective dose (Gy) for the whole body | 18-24 hours |
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