68 Ga PSMA PET/MRI for Hepatocellular Carcinoma

Ajit H. Goenka, MD

Status and phase

Completed

Early Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: 68Ga-PSMA-11 PET/MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT03982407

NCI-2019-08426 (Other Identifier)

18-011263

MC1944 (Other Identifier)

Details and patient eligibility

About

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

Full description

This is a prospective pilot proof-of-concept single-center study. Primary Objective Using surgical histopathology as the reference standard, the investigators intend to achieve the following objectives in adult subjects with Hepatocellular Carcinoma (HCC) undergoing surgical resection or transplant:

To demonstrate the feasibility of 68Ga-PSMA-PET/MRI for imaging patients with HCC
To estimate the sensitivity of SUVmax on PSMA PET for identification of LI-RADS® 5 (definitely HCC) observations or biopsy proven HCC(s).
To perform a Radiology-Pathology correlation of PSMA uptake at PET with HCC tumor PSMA immunostaining, tumor pathology features, and signal and enhancement characteristics at MRI

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.