This pilot clinical trial studies individualized adaptive radiation therapy (RT) in treating patients with liver (hepatocellular) carcinoma. RT uses high energy x-rays to kill tumor cells and shrink tumors. Individualized adaptive RT involves assessing patients' liver function before and during RT to determine how well the liver is working and how much RT treatment patients need to receive. To assess liver function, patients undergo a blood test using an injected dye called indocyanine green solution and perfusion magnetic resonance imaging (MRI). Perfusion MRI also uses an injected dye in order to see blood flow through tissues, such as in the liver. Customizing RT to what the liver can safely tolerate and how much of tumor needs to be killed may be a better treatment for patients with hepatocellular carcinoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02460835.
PRIMARY OBJECTIVES:
I. Establish the feasibility of the proposed adaptive treatment strategy.
II. Obtain preliminary estimates of the safety and efficacy of individualized adaptive RT.
SECONDARY OBJECTIVES:
I. To collect data on biomarkers of treatment efficacy, toxicity, and liver function to plan further enhancements to individualized RT.
II. To determine the correlation between indocyanine green solution retention rate at 15 minutes (min) (ICGR15) and half-life assessed via standard procedures versus (vs.) using LiMON non-invasive technology.
III. To determine the change in quality of life during and after RT.
OUTLINE:
Patients receive indocyanine green solution intravenously (IV) and undergo perfusion MRI within 4 weeks prior to start of RT, at approximately 4-6 weeks after completion of 3/5 RT planned treatments, and approximately 1-3 months after completion of RT.
Patients undergo RT over 5-20 fractions as determined by the maximum tumor dimension. Patients experiencing liver function decline after the first 3/5 RT treatments and does not recover sufficiently for additional therapy are considered to have completed treatment.
After completion of study treatment, patients are followed up at approximately 1 month and then approximately every 3-6 months for 2 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorMary U. Feng
