This clinical trial studies how well hepatobiliary iminodiacetic acid scan and magnetic resonance imaging guided stereotactic body radiation therapy works in treating patients with liver cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Adding two imaging scans to the standard radiation planning process may help doctors administer less radiation to the healthy liver tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03338062.
PRIMARY OBJECTIVE:
I. To assess whether theragnostically planned liver radiation through the use of a hepatobiliary iminodiacetic acid (HIDA) scan can reduce the dose of radiation to functional liver as compared to conventionally planned liver radiation.
SECONDARY OBJECTIVES:
I. To assess the rate at which the theragnostically planned radiation plan is chosen as the actual treatment plan instead of the conventionally planned radiation plan.
II. To collect data regarding local control (LC), progression free survival (PFS), overall survival (OS), time to transplant (TT), distant liver failure, and salvage therapy in patients undergoing functional image-guided planning for liver stereotactic body radiation therapy (SBRT).
III. To document patterns of failure so that local failure versus distant liver failure can be accounted for.
IV. To assess treatment toxicity.
EXPLORATORY OBJECTIVES:
I. To identify correlations between radiation dose to the normal liver and the risk of radiation-induced liver disease (RILD).
II. To determine the feasibility of incorporating functional liver magnetic resonance imaging (MRI) (i.e., functional [f]MRI which will be done via MRI with Eovist contrast) into theragnostic liver radiotherapy planning.
III. To assess the rate of significant change in HIDA and fMRI scans midway through treatment.
OUTLINE:
Patients undergo a HIDA scan and fMRI within 8 weeks of computed tomography (CT) simulation. Patients without cirrhosis or with Child-Turcotte-Pugh (CTP) A disease undergo SBRT for 3 fractions and patients with CTP B cirrhosis undergo SBRT for 5 fractions. Patients also undergo a HIDA scan midway through radiation treatment and a HIDA scan and fMRI at 3, 6, and 12 months post-treatment.
After completion of study treatment, patients are followed up at 30 days and then 3, 6, and 12 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorRyan Matthew Rhome