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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210027
• Other study ID #: UMCC 2006.067
• Secondary ID: HUM 5910R01CA132
• Status: Completed
• Start date: March 2007
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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