Overview

68 Ga PSMA PET/MRI for Hepatocellular Carcinoma

Status:
Active, not recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
All
Summary
This is a pilot study to investigate the evaluate to use of a drug/radiopharmaceutical called Gallium-68 PSMA-11 (68Ga-PSMA-11) for use in PET/MRI evaluation of hepatocellular carcinoma
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ajit H. Goenka, MD
Treatments:
Gallium 68 PSMA-11
Criteria
Inclusion Criteria:

- Patients at risk for HCC with either an imaging diagnosis of HCC by ceCT or ceMRI
(LI-RADS 5) confirmed by a board-certified abdominal radiologist or biopsy-proven HCC
confirmed by a hepatobiliary pathologist

- No prior treatment for HCC

- Subjects who are expected to undergo surgical resection of the hepatic lesion(s)
and/or liver transplant

- Male or female with age greater than 18 years, with the capacity to give informed
consent and willingness to provide a written 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

- 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 scanner.

- Subjects with contraindication to MRI including: 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

- Subjects with history of allergic response to radiocontrast media

- Subjects with known history of claustrophobia.