Recruitment

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