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Hepatocellular CarcinomaPhase 2NCT04762888

68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer

A Phase 2 study testing Computed Tomography, Gallium Ga 68 Gozetotide and Magnetic Resonance Imaging in people with Hepatocellular Carcinoma, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Computed Tomography, Gallium Ga 68 Gozetotide and Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
24 Feb 2021to 26 Jun 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Computed Tomography, Gallium Ga 68 Gozetotide, Magnetic Resonance Imaging, Positron Emission Tomography
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Undergo PET/CT

  • Gallium Ga 68 GozetotideDrug

    Also called (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

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI

    Undergo PET/MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    PET/MRI or PET/CT

Study groups in NCT04762888
Study groupRoleWhat they receive
Diagnostic (68Ga-PSMA PET/MRI or PET/CT)ExperimentalPatients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
Receives: Procedure: Computed Tomography; Drug: Gallium Ga 68 Gozetotide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of HCC Lesions With High PSMA Uptake on Baseline 68Ga-PSMA-11 PET

    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.

    Measured: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.

  2. Semi-Quantitative 68Ga-PSMA-11 PET Standardized Uptake Value (SUV) Metrics in HCC Lesions With High PSMA Uptake

    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).

    Measured: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.

  3. Semi-Quantitative 68Ga-PSMA-11 PET Tumor-to-Liver Background Ratio (TBR) Metrics in HCC Lesions With High PSMA Uptake

    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.

    Measured: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start24 Feb 2021
  3. Primary completion26 Jun 2025
  4. Study completion26 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04762888
Sponsor's protocol ID
20-006433
Other IDs
NCI-2021-01092, W81XWH-20
Status last verified
Jul 2026
First submitted
11 Feb 2021
Last updated
12 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Thompson SM, Suman G, Torbenson MS, Chen ZE, Jondal DE, Patra A, Ehman EC, Andrews JC, Fleming CJ, Welch BT, Kurup AN, Roberts LR, Watt KD, Truty MJ, Cleary SP, Smoot RL, Heimbach JK, Tran NH, Mahipal A, Yin J, Zemla T, Wang C, Fogarty Z, Jacobson M, Kemp BJ, Venkatesh SK, Johnson GB, Woodrum DA, Goenka AH. PSMA as a Theranostic Target in Hepatocellular Carcinoma: Immunohistochemistry and 68 Ga-PSMA-11 PET Using Cyclotron-Produced 68 Ga. Hepatol Commun. 2022 May;6(5):1172-1185. doi: 10.1002/hep4.1861. Epub 2021 Nov 15.

    PubMed 34783177

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computed Tomography, Gallium Ga 68 Gozetotide and Magnetic Resonance Imaging in people with Hepatocellular Carcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04762888, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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