PET-CT in Determining the Radioembolization Dose Delivered to Patients With Liver Metastasis, Primary Liver Cancer, or Biliary Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adult Primary Hepatocellular Carcinoma
- Advanced Adult Primary Liver Cancer
- Metastatic Extrahepatic Bile Duct Cancer
- Recurrent Adult Primary Liver Cancer
- Recurrent Extrahepatic Bile Duct Cancer
- Stage D Adult Primary Liver Cancer (BCLC)
- Unspecified Adult Solid Tumor - Protocol Specific
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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...
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.
Tracking Information
- NCT #
- NCT02088775
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Joshua Meyer, MD Fox Chase Cancer Center