68Ga PSMA PET Imaging for the Treatment of Advanced Liver Cancer

Phase 2

Active, not recruiting

• Conditions: Advanced Hepatocellular Carcinoma; Stage III Hepatocellular Carcinoma AJCC v8; Stage IV Hepatocellular Carcinoma AJCC v8; Unresectable Hepatocellular Carcinoma
• Interventions: Procedure: Computed Tomography; Drug: Gallium Ga 68 Gozetotide; Procedure: Positron Emission Tomography

• Registration Number: NCT05176223
• Lead Sponsor: Mayo Clinic

Brief Summary

This phase II trial tests whether 68-Gallium prostate specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) imaging can improve the diagnosis and management of liver cancer that has spread to other parts of the body (advanced). PSMA is a protein that appears in large amounts on the surface of liver cancer 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. A PET scan is then used to detect the location of the tumor cells. 68Ga-PSMA PET may improve upon the diagnosis and management of liver cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To test the performance of novel biomarkers derived from PSMA PET/computed tomography (CT) to measure response compared to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, in advanced hepatocellular carcinoma (HCC) patients treated with immunotherapy.

II. To identify precision imaging biomarkers that can predict response of HCC to novel immunotherapy.

OUTLINE:

Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed-up every 6 months for 3 years.

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-04
• Study Start: 2022-01-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-25
• Last Update Posted: 2025-08-29
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies
• Have radiographically measurable disease by RECIST
• Eligible for atezolizumab/bevacizumab front line therapy
• Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent

Exclusion Criteria

• 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/CT scanner

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (68GA PSMA PET/CT)	Computed Tomography	Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity.
Treatment (68GA PSMA PET/CT)	Positron Emission Tomography	Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity.
Treatment (68GA PSMA PET/CT)	Gallium Ga 68 Gozetotide	Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Time to treatment response	Up to 12 cycles of treatment or 36 weeks	Defined as the time from study registration to complete response/partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and per PSMA positron emission tomography (PET)/computed tomography (CT).
Progression free survival (PFS) at 6 months	At 6 months	Defined as the length of time during and after treatment that a patient lives with cancer without the disease worsening, per RECIST and PSMA PET/CT
Time to progression	Up to 3 years	Defined as the time from study registration to disease progression per RECIST 1.1 and PSMA PET/CT.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States