A 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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.
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).

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2023
Study completion: 2023
First posted: Sep 28, 2010
Registry last updated: Dec 5, 2024

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.

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

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