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

Mayo Clinic29 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Hepatocellular Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to treatment response

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).

Time frame: Up to 12 cycles of treatment or 36 weeks

Progression free survival (PFS) 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 frame: At 6 months

Time to progression

Defined as the time from study registration to disease progression per RECIST 1.1 and PSMA PET/CT.

Time frame: Up to 3 years