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
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|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|
- 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.
- 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).
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
|United States, Michigan|
|University of Michigan Rogel Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Theodore Lawrence, MD, PhD||University of Michigan Rogel Cancer Center|