Clinical trial NCT03982407: 68 Ga PSMA PET/MRI for Hepatocellular Carcinoma
Official title: Pilot Study of Integrated Time-of-Flight (TOF) 68 GA-PSMA - Gadoxetate PET/MR for Evaluation of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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:

1. To demonstrate the feasibility of 68Ga-PSMA-PET/MRI for imaging patients with HCC
2. To estimate the sensitivity of SUVmax on PSMA PET for identification of LI-RADS® 5 (definitely HCC) observations or biopsy proven HCC(s).
3. 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

Eligibility 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.

Primary outcomes:
measure: Evaluation of PSMA PET-MR for identification of intra and extrahepatic hepatocellular carcinoma in patients
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ajit H Goenka, MD
role: PRINCIPAL_INVESTIGATOR
References: