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PSMA PET/MRI or PSMA PET/CT for Evaluation of Hepatocellular Carcinoma

PSMA PET/MRI or PSMA PET/CT for Evaluation of Hepatocellular Carcinoma

Recruiting
18 years and older
All
Phase 2

Overview

The purpose of this research is to know whether 68Ga-PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of hepatocellular carcinoma.

Description

As part of this proposal, we seek to combine the molecular information obtained from PSMA PET with high-resolution anatomic and functional information from simultaneously acquired contrast-enhanced MRI, the current gold standard for HCC imaging, or contrast-enhanced CT to evaluate PSMA as both a diagnostic and therapeutic response imaging biomarker.

  1. Better characterize the uptake of PSMA in HCC. This would be a first step towards determining if 68Ga-PSMA PET/MRI (or PET/CT) consisting of focused liver acquisition and whole-body acquisition can be a 'one-stop-shop' for evaluating primary intrahepatic and metastatic extrahepatic hepatocellular carcinoma.
  2. Establish PSMA as an imaging biomarker for treatment response assessment in HCC for translation to practice and to clinical trials
  3. Establish PSMA as a theranostic target for 177Lu-PSMA-radio-ligand therapy as a novel therapeutic option for HCC

Eligibility

Inclusion Criteria:

  • Patients with either an imaging diagnosis of HCC by CT or MRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
  • No prior treatment for HCC
  • Subjects who may undergo hepatic surgical resection, liver transplant or hepatic locoregional therapy (ablation, embolization)
  • Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed 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 (relevant to PET/MRI)
  • 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 or PET/CT scanner.
  • Subjects with contraindication to MRI (relevant to PET/MRI):
  • 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

Study details
    Adenocarcinoma
    malignant adenoma
    Adenocarcinoma
    HEPATIC NEOPLASM
    liver cancer
    HEPATOCELLULAR CARCINOMA
    liver cancer
    malignant adenoma

NCT04310540

Mayo Clinic

19 February 2024

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