68 Ga PSMA PET/MRI for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Pilot Study of Integrated Time-of-Flight (TOF) 68 GA-PSMA - Gadoxetate PET/MR for Evaluation of Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: 68Ga-PSMA-11 PET/MRI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ga68 PSMA PET-MR<br>68Ga labeled PSMA -11 (or PSMA-HBED_CC) PET/MRI scan | Drug: 68Ga-PSMA-11 PET/MRI<br>* The PET/MRI exam-related patient visit will last approximately 2 to 2.5 hours, including 30-minute nursing assessment, 45-60 minutes for PSMA uptake and 60 minutes for PET/MRI scan. They will be contacted within the next 72 hours to complete a brief phone survey.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of PSMA PET-MR for identification of intra and extrahepatic hepatocellular carcinoma in patients | Sensitivity of PSMA PET-MRI for detection of LI-RADS 5 (definitely HCC) lesions on a per-lesion basis with histopathology as the gold standard. We will perform a Radiologic-pathologic correlation comparing HCC PSMA SUVmax with tumor PSMA immunostaining positivity. | 18 months |