Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hepatocellular Carcinoma
Type
Interventional
Phase
Phase 2
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 evaluate the feasibility and diagnostic performance of gallium Ga 68 gozetotide (68Ga PSMA)-dual contrast PET/MRI for detection and staging of hepatocellular carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. II. To identify the biologic correlates of b...

PRIMARY OBJECTIVES: I. To evaluate the feasibility and diagnostic performance of gallium Ga 68 gozetotide (68Ga PSMA)-dual contrast PET/MRI for detection and staging of hepatocellular carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. II. To identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC. OUTLINE: Patients receive 68Ga-PSMA intravenously (IV) over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.

Tracking Information

NCT #
NCT04762888
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ajit H Goenka Mayo Clinic in Rochester