NCT04762888

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

Completed Phase 2 Last updated 31 October 2025

What this trial tests

Phase 2 trial testing Computed Tomography in Hepatocellular Carcinoma in 52 participants. Completed in 26 June 2025.

Timeline

24 February 2021

Primary endpoint
26 June 2025

26 June 2025

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	52
Start date	24 February 2021
Primary completion	26 June 2025
Estimated completion	26 June 2025
Sites	1 location across United States

Drugs / interventions tested

• Computed Tomography
• Gallium Ga 68 Gozetotide — full drug profile →
• Magnetic Resonance Imaging
• Positron Emission Tomography

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Functional Imaging of Liver Cancer (FLIC): Study protocol of a phase 2 trial of 18F-DCFPyL PET/CT imaging for patients with hepatocellular carcinoma.
   Mena E, Shih J, Chung JY, Jones J, et al · · 2022 · cited 6× · PMID 36367894 · DOI 10.1371/journal.pone.0277407
2. Imaging of Tumor-Associated Vascular Prostate-Specific Membrane Antigen in Woodchuck Model of Hepatocellular Carcinoma.
   Sergeeva O, Zhang Y, Julian W, Sasikumar A, et al · · 2022 · cited 2× · PMID 35844243 · DOI 10.1016/j.gastha.2022.04.014
3. Diagnosis and Treatment Response Monitoring of Liver Cancer Using Glypican-3-Targeted Single-Domain Antibody PET.
   Fayn S, Lee W, Basuli F, Shi J, et al · · 2025 · cited 1× · PMID 41105446 · DOI 10.1158/1078-0432.ccr-25-2587