Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
50

Summary

Conditions
  • Adult Hepatocellular Carcinoma
  • Benign Liver Tumor
  • Cholangiocarcinoma
  • Metastases to Liver
  • Resectable Hepatocellular Carcinoma
Type
Interventional
Phase
Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Cohorts A and B are Parallel. Cohorts C and D are Single Group.Masking: 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 evaluate the relationship between 18F-FSPG PET/computed tomography (CT), pathology, and cancer metabolism in patients with suspected hepatocellular carcinoma (HCC) scheduled for liver resection surgery and orthotopic liver transplant (OLT). II. To compare 18F-FSPG PET/CT wi...

PRIMARY OBJECTIVES: I. To evaluate the relationship between 18F-FSPG PET/computed tomography (CT), pathology, and cancer metabolism in patients with suspected hepatocellular carcinoma (HCC) scheduled for liver resection surgery and orthotopic liver transplant (OLT). II. To compare 18F-FSPG PET/CT with standard-of-care (SOC) diagnostic MRI imaging in patients with suspected HCC scheduled for liver resection surgery or OLT. III. To compare the uptake of 18F-FSPG PET/CT with 11C-acetate PET/CT AND 18F-FDG PET/CT in suspected HCC and background liver in patients scheduled for liver resection surgery or OLT. IV. To evaluate uptake of 18F-FSPG PET/CT in benign liver lesions compared to background. V. To evaluate uptake of 18F-FSPG PET/CT in malignant non-HCC liver tumors. OUTLINE: Patients undergo 18F-FSPG PET and either carbon-11 (11C)-acetate PET or 18F-FDG PET scans within 4 weeks of surgery or OLT.

Tracking Information

NCT #
NCT02379377
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sunil Geevarghese, MD Vanderbilt-Ingram Cancer Center