A Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion
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ClinicalTrials.gov Identifier: NCT01210027 |
Recruitment Status :
Recruiting
First Posted : September 28, 2010
Last Update Posted : December 20, 2021
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Condition or disease |
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Liver Cancer |
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 : | November 2022 |
Estimated Study Completion Date : | November 2022 |
- 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).

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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 |
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

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
Contact: Cancer Answer Line | 1-800-865-1125 | canceranswerline@umich.edu |
United States, Michigan | |
University of Michigan Rogel Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Theodore Lawrence, MD, PhD | University of Michigan Rogel Cancer Center |
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: | December 20, 2021 |
Last Verified: | December 2021 |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Liver Diseases |