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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2023
Source Sirtex Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

Country Name City State
United States Inland Imaging Spokane Washington

Sponsors (2)

Lead Sponsor Collaborator
Sirtex Medical Bright Research Partners

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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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