A Study to Evaluate 68Ga- PSMA-Dual Contrast PET/MRI and PET/CT for Hepatocellular Carcinoma

Overview

About this study

The purpose of this study is to evaluate the feasibility and diagnostic performance of 68Ga PSMA-dual contrast PET/MRI for detection and staging of Hepatocellular Carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. Additionally, this study aims to identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Patients with either an imaging diagnosis of HCC by CT or MRI (Liver Imaging Reporting
and Data System [LI-RADS] 5) confirmed by a board-certified abdominal radiologist, or
with biopsy-proven HCC

- No prior treatment for HCC

- Patients who may undergo hepatic surgical resection or liver transplant

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

Exclusion Criteria:

- Patients requiring emergent surgery for a ruptured/bleeding HCC

- Bilirubin > 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast
agent (relevant to PET/MRI)

- Patients with glomerular filtration rate (GFR) < 30 ml/min/1.73m^2, on dialysis, or
with acute kidney injury

- Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of
the PET scan

- Patients with higher than the weight/size limitations of PET/MRI or PET/CT scanner

- Subjects with history of allergic response to Eovist or Gadavist

- Subjects with known history of claustrophobia

- Subjects with GFR < 30 ml/min/1.73m^2, on dialysis, or with acute kidney injury

- Subjects with a history of severe hypersensitivity to Eovist or Gadavist

- Patients with contraindication to MRI (relevant to PET/MRI):

- Patients who have a heart pacemaker

- Patients who have a metallic foreign body (metal sliver) in their eye, or who
have an aneurysm clip in their brain

- Patients who have implanted devices with magnets

- Patients who have other implanted electronic devices

- Patients who have deep brain stimulator

- Patients who have vagal nerve stimulator

- Patients with cochlear (ear) or auditory implants

Eligibility last updated 6/30/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ajit Goenka, M.D.

Open for enrollment

Contact information:

Kurt Kevin Degillo CCRP

(507) 422-5407

Degillo.Kurt@mayo.edu

More information

Publications

Publications are currently not available
.

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