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

Completed

• Conditions: Liver Cancer

• Registration Number: NCT01210027
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of Liver Function Before, During and After Radiation	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.

Secondary Outcome Measures

Name	Time	Method
Measure of Liver Perfusion	Follow-up - Approximately 7 Years	Develop a model to predict post-treatment liver perfusion based on pre-treatment perfusion, intratreatment perfusion, and radiation dose.
Association Between Liver Perfusion and Changes in Tumor and Clinical Outcomes	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).

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States