68 Ga PSMA PET/MRI for Hepatocellular C… | Clinical Trial

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-PSMA-11 PET/MRI

Drug

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.

Primary outcomes

Evaluation of PSMA PET-MR for identification of intra and extrahepatic hepatocellular carcinoma in patients

Time frame: 18 months

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.

Sponsors and collaborators

Lead sponsor

Ajit H. Goenka, MD

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2022
First posted: Jun 11, 2019
Registry last updated: Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed