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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01210027
Enrollment
143
Registered
2010-09-28
Start date
2007-03-31
Completion date
2023-04-01
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

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.

Interventions

None listed

Sponsors

University of Michigan Rogel Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of Liver Function Before, During and After Radiation2-3 months for treatment; indefinite for follow-upThe 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

MeasureTime frameDescription
Measure of Liver PerfusionFollow-up - Approximately 7 YearsDevelop 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 OutcomesFollow-up - Approximately 7 yearsExplore 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026