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

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ClinicalTrials.gov Identifier: NCT01210027
Recruitment Status : Suspended (Enrollment and/or interactions/interventions temporarily paused due to COVID-19 and expected to resume in the future. This is not a suspension of IRB approval.)
First Posted : September 28, 2010
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Description
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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.

Condition or disease
Liver Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion
Actual Study Start Date : March 2007
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have one of the following: primary hepatocellular cancer, hepatobiliary cancer, or metastatic disease to the liver.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210027


Locations
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United States, Michigan
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Theodore Lawrence, MD, PhD University of Michigan Rogel Cancer Center
More Information
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT01210027    
Other Study ID Numbers: UMCC 2006.067
HUM 5910 ( Other Identifier: University of Michigan IRBMED )
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases