68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer
July 21, 2026 updated by: Ajit H. Goenka, MD, Mayo Clinic
Early Detection, Accurate Staging, and Biologic Characterization of HCC With Hybrid 68Ga-PSMA-Dual -Contrast PET/MRI and PET/CT Using Cyclotron-Produced 68Ga
This phase II trial studies how well 68Ga-PSMA PET/MRI or PET/CT works in early detection of liver cancer.
68Gallium-PSMA is a radioactive tracer designed to circulate through the body and attach itself to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells.
Magnetic resonance imaging (MRI) is a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues, and structures within the body.
Positron emission tomography (PET) is 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 (tracer) to show this activity.
Computed tomography (CT) scan uses X-rays to create images of the bones and internal organs within your body.
Combining a PET scan with an MRI or CT scan may help make the images easier to interpret.
This trial may help determine if 68Ga- PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer in the future.
Study Overview
Status
Completed
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and diagnostic performance of gallium Ga 68 gozetotide (68Ga PSMA)-dual contrast PET/MRI for detection and staging of hepatocellular carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging.
II. To identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC.
OUTLINE:
Patients receive 68Ga-PSMA intravenously (IV) over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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 Hepatocellular carcinoma (HCC) by Computed Tomography (CT) or Magnetic Resonance Imaging MRI (Liver Imaging Reporting and Data System [LI-RADS] 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
- Subjects who may undergo hepatic surgical resection, liver transplant, or hepatic locoregional therapy (LRT) (e.g., ablation, embolization, etc.)
- No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm). Patients that have been previously treated with HCC, but have new or reoccurring untreated lesions, are included in the study.
- 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 positron emission tomography [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
PSMA PET/CT will be an alternative in this study for patients who are unable to undergo PET/MRI for any reason but are otherwise eligible for the study.
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 (68Ga-PSMA PET/MRI or PET/CT)
Patients receive 68Ga-PSMA IV over 90 minutes.
Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
|
Given IV
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/MRI
Other Names:
PET/MRI or PET/CT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of HCC Lesions With High PSMA Uptake on Baseline 68Ga-PSMA-11 PET
Time Frame: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
|
Treatment-naïve hepatocellular carcinoma (HCC) lesions were evaluated qualitatively on baseline 68Ga-PSMA-11 PET.
Grade 1 indicated uptake less than normal liver.
Grade 2 indicated uptake equal to normal liver.
Grade 3 indicated uptake greater than normal liver.
Grade 4 indicated uptake greater than spleen or kidneys.
High PSMA uptake was defined as grade 3 or 4. Low PSMA uptake was defined as grade 1 or 2.
|
Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
|
|
Semi-Quantitative 68Ga-PSMA-11 PET Standardized Uptake Value (SUV) Metrics in HCC Lesions With High PSMA Uptake
Time Frame: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
|
Semi-quantitative PET metrics were calculated in HCC lesions showing high qualitative PSMA uptake using gradient-based volume-of-interest segmentation.
Reported metrics were maximum SUV (SUVmax) and mean SUV (SUVmean).
|
Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
|
|
Semi-Quantitative 68Ga-PSMA-11 PET Tumor-to-Liver Background Ratio (TBR) Metrics in HCC Lesions With High PSMA Uptake
Time Frame: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
|
Semi-quantitative PET tumor-to-liver background ratio (TBR) metrics were calculated in HCC lesions showing high qualitative PSMA uptake using gradient-based volume-of-interest segmentation.
Reported metrics were TBRmax and TBRmean.
|
Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
February 24, 2021
Primary Completion (Actual)
June 26, 2025
Study Completion (Actual)
June 26, 2025
Study Registration Dates
First Submitted
February 11, 2021
First Submitted That Met QC Criteria
February 16, 2021
First Posted (Actual)
February 21, 2021
Study Record Updates
Last Update Posted (Actual)
August 12, 2026
Last Update Submitted That Met QC Criteria
July 21, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Liver Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Investigative Techniques
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Magnetic Resonance Spectroscopy
- gallium 68 PSMA-11
- 68Ga-DKFZ-PSMA-11
Other Study ID Numbers
- 20-006433
- NCI-2021-01092 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- W81XWH-20 (Other Grant/Funding Number: U.S. Army Medical Research Acquisition Activity (USAMRAA))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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