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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Liver Function Before, During and After Radiation | 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 | 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 | 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 |