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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

Tracking Information
First Submitted Date September 2, 2010
First Posted Date September 28, 2010
Last Update Posted Date January 22, 2021
Actual Study Start Date March 2007
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 27, 2010)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 27, 2010)
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion
Official Title A Pilot Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Liver Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: May 18, 2015)
140
Original Estimated Enrollment
 (submitted: September 27, 2010)
20
Estimated Study Completion Date October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01210027
Other Study ID Numbers UMCC 2006.067
HUM 5910 ( Other Identifier: University of Michigan IRBMED )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Michigan Rogel Cancer Center
Study Sponsor University of Michigan Rogel Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Theodore Lawrence, MD, PhD University of Michigan Rogel Cancer Center
PRS Account University of Michigan Rogel Cancer Center
Verification Date January 2021