Skip to main content
OpenTrials
Completed

NCT Number: NCT05848947

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carcinoma Adenocarcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasm Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inland Imaging

Spokane, Washington, 99208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Patients who are contraindicated for 99mTc-MAA per the manufacturer's package insert

Treatment and study plan

99mTc-Macro Albumin Aggregate

Drug

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.

Primary outcomes

  1. Mean Absorbed Dose (Gy) for the Whole Body

    Time frame: 18-24 hours

  2. Mean Absorbed Dose (Gy) for Critical Non-liver Organs

    Time frame: 18-24 hours

  3. Mean Activity (Bq) for the Whole Body

    Time frame: 18-24 hours

  4. Mean Activity (Bq) for Critical Non-liver Organs

    Time frame: 18-24 hours

  5. Effective Dose (Gy) for the Whole Body

    Time frame: 18-24 hours

Sponsors and collaborators

Lead sponsor

Sirtex Medical

Industry

Collaborators

  • Bright Research Partners

Registry information

Official study title

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

Acronym: MAApping

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 8, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.