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68 Ga PSMA PET/MRI for Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03982407
Recruitment Status : Enrolling by invitation
First Posted : June 11, 2019
Last Update Posted : July 1, 2019
Information provided by (Responsible Party):
Ajit H. Goenka, MD, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: 68Ga-PSMA-11 PET/MRI Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of Integrated Time-of-Flight (TOF) 68 GA-PSMA - Gadoxetate PET/MR for Evaluation of Hepatocellular Carcinoma
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2022

Arm Intervention/treatment
Experimental: Ga68 PSMA PET-MR
68Ga labeled PSMA -11 (or PSMA-HBED_CC) PET/MRI scan
Drug: 68Ga-PSMA-11 PET/MRI
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 Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03982407

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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Ajit H. Goenka, MD
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Principal Investigator: Ajit H Goenka, MD Mayo Clinic

Additional Information:
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Responsible Party: Ajit H. Goenka, MD, Principal Investigator, Mayo Clinic Identifier: NCT03982407     History of Changes
Other Study ID Numbers: 18-011263
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases