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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Stage IV Hepatocellular Carcinoma AJCC v8; Unresectable Hepatocellular Carcinoma; Stage III Hepatocellular Carcinoma AJCC v8; Advanced Hepatocellular Carcinoma

Treatments: Procedure: Positron Emission Tomography; Drug: Gallium Ga 68 Gozetotide; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05176223

21-007799 (Other Identifier)

NCI-2021-12377 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Treatment (68GA PSMA PET/CT)

Experimental group

Description:

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:

Procedure: Computed Tomography

Drug: Gallium Ga 68 Gozetotide

Procedure: Positron Emission Tomography