PET-CT in Determining the Radioembolization Dose Delivered to Patients With Liver Metastasis, Primary Liver Cancer, or Biliary Cancer

PRIMARY OBJECTIVES: I. To determine the relationship between radiation dose to 70% of the tumor volume as determined by post-treatment positron emission tomography (PET)-computed tomography (CT) and local control at 6 months. SECONDARY OBJECTIVES: I. To evaluate the ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs. II. To determine the stability of microsphere location by examining the changes in dose in a subset of patients with PET-CT scans performed on day 0 and day 1. III. To determine the relationship of dose predicted by technetium-99m (Tc-99m) labeled Macro-aggregated albumin (MAA) imaged using single-photon emission computed tomography (SPECT) versus post-treatment dosimetry. IV. To determine the effect of dose delivered on local control and normal tissue complications. V. To measure the perfusion of the tumor for correlation with dose deposition, based on arterial phase CT measurements. OUTLINE: Patients undergo PET-CT scan before and after standard radioembolization on day 0. A subset of patients undergo PET-CT scan on day 1, 24 hours after the day 0 post-treatment PET-CT. After completion of study treatment, patients are followed up at 1 week, 1 and 3 months, every 3 months for 1 year, every 6 months for 1 year and then annually for 3 years. Although the study uses radiation-emitting imaging devices (PET/CT and SPECT) and standard-of-care Y-90 radioembolization, the clinical investigation does not study the performance, effect, safety, effectiveness, design, or intended use of an FDA-regulated device product. The research objectives are limited to characterization of radiation dose distribution and correlation of dosimetry with clinical outcomes; therefore, the study does not "Study a U.S. FDA-regulated Device Product" within the meaning of 42 CFR Part 11