SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA

Carcinoma, Hepatocellular Clinical Trial

— MAApping  

Official title:

Study to Calculate the Radiation-Absorbed Dose of Technetium-99m Macroaggregated Albumin (99mTc-MAA) to the Whole Body and Non-Liver Critical Organs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05848947
• Other study ID #: STX2301
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Neoplasm
• Liver Neoplasms

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