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MRI in Predicting Liver Toxicity in Patients with Liver or Intrahepatic Bile Duct Cancer Undergoing Radiation Therapy

Trial Status: Active

This pilot clinical trial studies magnetic resonance imaging (MRI) in predicting liver toxicity in patients with liver or intrahepatic bile duct cancer undergoing radiation therapy (RT). MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. Imaging procedures, such as MRI, may help doctors predict which patients will develop liver toxicity and help plan the best treatment.

Inclusion Criteria

  • Patients will have one of the following diseases: primary hepatocellular cancer, hepatobiliary cancer, or metastatic disease to the liver
  • The patient’s planned cancer management is radiation to the liver with or without chemotherapy
  • Women who are pregnant or breastfeeding are excluded; patients with reproductive potential must agree to use an effective contraceptive method during treatment
  • Prisoners are excluded
  • Patients must have a performance status of 0-2
  • Patients must have a life expectancy of at least 3 months
  • Patients should have no contraindications to having a contrast enhanced MRI scan; these contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Radiology Department
  • Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Hospital indicating that they are aware of the investigational nature of this MRI, of the potential but minimal risks of these additional scans, and that their treatments may or may not be altered by the results of these scans
  • Patients must also have a treatment plan that includes liver function assessment with indocyanine green (IC-GREEN)

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Dawn Owen
Phone: 734-647-9956

PRIMARY OBJECTIVES:

I. Describe the change over time in local perfusion in the “normal” liver parenchyma in patients undergoing fractionated radiation therapy.

II. Develop a model to predict post-treatment liver perfusion based on pretreatment perfusion, intratreatment perfusion, and radiation dose.

III. Compare liver perfusion measured by dynamic contrast enhanced (DCE) MRI with a standard liver function index measured by indocyanine green (that is obtained from a parallel protocol, for which these patients will be eligible, or from clinical care).

IV. Explore the association between liver perfusion changes in tumor and clinical outcomes, including the size of tumor; local tumor progression; distant metastases; and toxicity (radiation-induced liver disease).

V. Assess test and re-test reproducibility of MRI perfusion in the liver.

OUTLINE:

Patients undergo liver MRI perfusion scan within 2 weeks prior to RT or 2 scans 2-10 days apart prior to RT. Patients whose treatment prescription includes a planned treatment break (4-6 weeks), undergo second MRI scan in the second half of the treatment break, prior to the start of the second course of treatment. Patients whose treatment is to continue without a break, undergo MRI scan after an accumulative radiation dose between 60% to 80% of prescribed dose. Patients undergo an additional MRI scan one month after completion of treatment and may undergo another scan 2-3 months after completion of RT.

After completion of study treatment, patients are followed up at 4 weeks, 2-3 months, and 6 months.

Trial Phase Phase NA

Trial Type Screening

Lead Organization
University of Michigan Comprehensive Cancer Center

Principal Investigator
Dawn Owen

  • Primary ID UMCC 2006.067
  • Secondary IDs NCI-2011-03601
  • Clinicaltrials.gov ID NCT01210027