A Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion

March 13, 2024 updated by: University of Michigan Rogel Cancer Center

A Pilot Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion

Researchers at the the University of Michigan are conducting a research project to assess how a course of radiation therapy changes the way blood flows through the liver. To be able to do this, the researchers will be using MRI (magnetic resonance imaging) scans completed before, during, and after radiation therapy. MRI's will be done on 4 or 5 occasions. On each occasion, you will be injected with a fluid called gadolinium (a contrast agent) before getting an MRI. This contrast agent makes it easier for the Researchers to see your organs in the scans, and causes any abnormal areas to become very bright on the MRI. This agent will be injected into a vein in your arm or leg. Each MRI scan will last approximately 45 minutes.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Rogel Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have one of the following: primary hepatocellular cancer, hepatobiliary cancer, or metastatic disease to the liver.

Description

Inclusion Criteria:

  • Patients must be ≥18 years of age.
  • The patient's planned cancer management is radiation to the liver with or without chemotherapy.
  • Patients must have a performance status of 0-2 and a life expectancy of at least 3 months.
  • Patients should have no contraindications to having a contrast enhanced MRI scan.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding are excluded.
  • Prisoners are excluded

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of Liver Function Before, During and After Radiation
Time Frame: 2-3 months for treatment; indefinite for follow-up
The primary objective of this research is to assess how a course of radiation therapy changes the way blood flows through the liver. Researchers want to use the information collected from this research for future research, to see if this change in blood flow indicates that an individual patient is at higher risk for complications from the radiation therapy, specifically Radiation-Induced Liver Disease (RILD). To be able to do this, the researchers will be using MRI (magnetic resonance imaging) scans completed before, during, and after radiation therapy.
2-3 months for treatment; indefinite for follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of Liver Perfusion
Time Frame: Follow-up - Approximately 7 Years
Develop a model to predict post-treatment liver perfusion based on pre-treatment perfusion, intratreatment perfusion, and radiation dose.
Follow-up - Approximately 7 Years
Association Between Liver Perfusion and Changes in Tumor and Clinical Outcomes
Time Frame: Follow-up - Approximately 7 years
Explore the association between liver perfusion changes in tumor and clinical outcomes, including the size of tumor; local tumor progression; distant metastases; overall survival; and toxicity (radiation-induced liver disease).
Follow-up - Approximately 7 years

Collaborators and Investigators

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

Sponsor

University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Theodore Lawrence, MD, PhD, University of Michigan Rogel Cancer Center

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)

March 1, 2007

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimated)

September 28, 2010

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2006.067
  • HUM 5910 (Other Identifier: University of Michigan IRBMED)

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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