PSMA PET/MRI or PSMA PET/CT for Evaluation of Liver Cancer

PRIMARY OBJECTIVE:

I. To evaluate diagnostic performance of gallium Ga 68 gozetotide (68Ga-PSMA-dual contrast [Gadavist and gadoxetate]) positron emission tomography (PET)/magnetic resonance imaging (MRI) OR PET/computed tomography (CT) for hepatocellular carcinoma (HCC) using surgical histopathology (either resection, transplant or biopsy specimens) or Liver Imaging and Reporting Data System (LI-RADS) categorization as gold standard.

II. To evaluate treatment response after locoregional therapy or systemic therapy in HCC using 68Ga-PSMA uptake at PET (qualitative & semi-quantitative measures) and to compare it with standard CT/MRI morphologic and post-contrast enhancement based response criteria (modified Response Evaluation Criteria in Solid Tumors [mRECIST] and LI-RADS-treatment response [LR-TR] algorithm).

III. To determine association between PSMA uptake in HCCs at PET with tissue prostate specific membrane antigen (PSMA) expression using immunohistochemistry or serum/plasma PSMA expression using enzyme-linked immunosorbent assay (ELISA).

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV), and undergo PET/MRI over 60 minutes or PET/CT over 30 minutes at baseline and 12 weeks after completion of hepatic locoregional therapy or 8-12 weeks after completion of systemic therapy. Patients undergoing hepatic locoregional therapy may also undergo a liver biopsy.

Inclusion criteria

• Patients with either an imaging diagnosis of HCC by CT or MRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
• Subjects who may undergo hepatic surgical resection, liver transplant, hepatic locoregional therapy (ablation, embolization, etc.) or systemic therapy
• No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm)
• For the systemic therapy arm, patients who have had unequivocal progression after prior locoregional therapy (LRT) and/or those undergoing de novo systemic therapy in view of advanced HCC at diagnosis
• Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent

Exclusion criteria

• Subjects requiring emergent surgery for a ruptured/bleeding HCC
• Bilirubin > 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent (relevant to PET/MRI)
• Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan
• Subjects with higher than the weight/size limitations of PET/MRI or PET/CT scanner
• Subjects with contraindication to MRI (relevant to PET/MRI):

• Subjects who have a heart pacemaker
• Subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain
• Subjects who have implanted devices with magnets
• Subjects who have other implanted electronic devices
• Subjects who have deep brain stimulator
• Subjects who have vagal nerve stimulator
• Subjects with cochlear (ear) or auditory implants