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

January 8, 2025 updated by: Sirtex Medical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99208
        • Inland Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Absorbed Dose (Gy) for the Whole Body
Time Frame: 18-24 hours
18-24 hours
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Time Frame: 18-24 hours
18-24 hours
Mean Activity (Bq) for the Whole Body
Time Frame: 18-24 hours
18-24 hours
Mean Activity (Bq) for Critical Non-liver Organs
Time Frame: 18-24 hours
18-24 hours
Effective Dose (Gy) for the Whole Body
Time Frame: 18-24 hours
18-24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sirtex Medical

Collaborators

Bright Research Partners

Investigators

  • Principal Investigator: Douglas Murrey, MD, Inland Imaging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Actual)

July 5, 2023

Study Completion (Actual)

July 5, 2023

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STX2301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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