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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01210027.
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 PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorTheodore Steven Lawrence