PSMA PET/MRI or PSMA PET/CT for Evaluation of Liver Cancer

April 9, 2024 updated by: Mayo Clinic

Development and Validation of Innovative Hybrid Molecular Imaging, 68Ga-PSMA-Dual Contrast PET/MRI and 68Ga-PSMA PET/CT, to Transform the Care of Patients With Hepatocellular Carcinoma

This clinical trial evaluates whether 68Ga-PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer. MRI stands for magnetic resonance imaging, a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues and structures within the body. PET stands for positron emission tomography, an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. In patients that have been diagnosed with liver cancer, a protein called prostate specific membrane antigen (PSMA) appears in large amounts on the surface of the cancerous cells. The radioactive chemical compound (68Ga-PSMA) has been designed to circulate through the body and attach itself to the PSMA protein on liver cancer cells. 68Ga-PSMA PET/MRI or PET/CT may be better in diagnosing and managing liver cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate diagnostic performance of gallium Ga 68 gozetotide (68Ga-PSMA-dual contrast [Gadavist and gadoxetate]) positron emission tomography (PET)/magnetic resonance imaging (MRI) OR PET/computed tomography (CT) for hepatocellular carcinoma (HCC) using surgical histopathology (either resection, transplant or biopsy specimens) or Liver Imaging and Reporting Data System (LI-RADS) categorization as gold standard.

II. To evaluate treatment response after locoregional therapy or systemic therapy in HCC using 68Ga-PSMA uptake at PET (qualitative & semi-quantitative measures) and to compare it with standard CT/MRI morphologic and post-contrast enhancement based response criteria (modified Response Evaluation Criteria in Solid Tumors [mRECIST] and LI-RADS-treatment response [LR-TR] algorithm).

III. To determine association between PSMA uptake in HCCs at PET with tissue prostate specific membrane antigen (PSMA) expression using immunohistochemistry or serum/plasma PSMA expression using enzyme-linked immunosorbent assay (ELISA).

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV), and undergo PET/MRI over 60 minutes or PET/CT over 30 minutes at baseline and 12 weeks after completion of hepatic locoregional therapy or 8-12 weeks after completion of systemic therapy. Patients undergoing hepatic locoregional therapy may also undergo a liver biopsy.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • Subjects who may undergo hepatic surgical resection, liver transplant, hepatic locoregional therapy (ablation, embolization, etc.) or systemic therapy
  • No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm)
  • For the systemic therapy arm, patients who have had unequivocal progression after prior locoregional therapy (LRT) and/or those undergoing de novo systemic therapy in view of advanced HCC at diagnosis
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (gallium Ga 68 gozetotide PET/MRI, PET/CT, biopsy)
Patients receive gallium Ga 68 gozetotide IV, and undergo PET/MRI over 60 minutes or PET/CT over 30 minutes at baseline and 12 weeks after completion of hepatic locoregional therapy or 8-12 weeks after completion of systemic therapy. Patients undergoing hepatic locoregional therapy may also undergo a liver biopsy.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic resonance imaging (procedure)
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
Drug: Gallium Ga 68 Gozetotide
Given IV
Other Names:
  • (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68Ga)Glu-urea-Lys(Ahx)-HBED-CC
  • 68Ga-DKFZ-PSMA-11
  • 68Ga-HBED-CC-PSMA
  • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • 68Ga-PSMA
  • 68Ga-PSMA-11
  • 68Ga-PSMA-HBED-CC
  • [68Ga] Prostate-specific Membrane Antigen 11
  • [68Ga]GaPSMA-11
  • Ga PSMA
  • Ga-68 labeled DKFZ-PSMA-11
  • Ga-68 labeled PSMA-11
  • GA-68 PSMA-11
  • Gallium Ga 68 PSMA-11
  • Gallium Ga 68-labeled PSMA-11
  • GALLIUM GA-68 GOZETOTIDE
  • Gallium-68 PSMA
  • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • GaPSMA
  • PSMA-HBED-CC GA-68
Procedure: Positron Emission Tomography
Undergo PET
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Procedure: Biopsy
Undergo biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of 68Ga-PSMA-dual contrast (gadavist and gadoxetate) positron emission tomography/magnetic resonance imaging (PET/MRI), or 68Ga-PSMA positron emission tomography/computed tomography (PET/CT)
Time Frame: At 3 months after completion of hepatic locoregional therapy or systemic therapy
Using surgical histopathology (either resection or transplant specimens) or Liver Imaging and Reporting Data System (LI-RADS[R]) categorization as gold standard.
At 3 months after completion of hepatic locoregional therapy or systemic therapy
Treatment response after locoregional therapy in hepatocellular carcinoma (HCC)
Time Frame: Completion of locoregional therapy (up to 3 months)
Using 68Ga-PSMA uptake at PET (qualitative & semi-quantitative measures) compared with standard CT/MRI morphologic and post-contrast enhancement based response criteria (modified Response Evaluation Criteria in Solid Tumors and LI-RADS-treatment response [LR-TR] algorithm).
Completion of locoregional therapy (up to 3 months)
Association between prostate specific membrane antigen (PSMA) uptake in hepatocellular carcinoma at PET with tissue PSMA expression
Time Frame: Up to 3 years
Assessed using immunohistochemistry, serum/plasma PSMA expression using enzyme-linked immunosorbent assay or serum HCC tumor markers.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of treatment response after locoregional therapy in HCC
Time Frame: 4 months
68Ga-PSMA uptake at PET (qualitative & semi-quantitative measures) and to compare it with standard CT/MRI morphologic and post-contrast enhancement based response criteria [mRECIST and LI-RADS®-treatment response (LR-TR) algorithm].
4 months
Determine the association between PSMA uptake in HCCs at PET with tissue PSMA expression
Time Frame: 6 months
Sensitivity of PSMA expression using immunohistochemistry or serum/plasma PSMA expression using ELISA.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ajit H. Goenka, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2020

Primary Completion (Actual)

November 2, 2023

Study Completion (Actual)

November 2, 2023

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-012563
  • NCI-2021-02760 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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