PSMA PET/MRI or PSMA PET/CT for Evaluation of Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2023-03-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research is to know whether 68Ga-PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of hepatocellular carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

Criteria

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

• No prior treatment for HCC

• Subjects who may undergo hepatic surgical resection, liver transplant or hepatic locoregional therapy (ablation, embolization)

• 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