Clinical trial NCT05176223: 68Ga PSMA PET Imaging for the Treatment of Advanced Liver Cancer
Official title: Optimizing Outcomes of Patients with Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Stage III Hepatocellular Carcinoma AJCC V8
Stage IV Hepatocellular Carcinoma AJCC V8
Unresectable Hepatocellular Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to treatment response
timeFrame: 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), assessed up to 12 cycles of treatment or 36 weeks
measure: Progression free survival (PFS)
timeFrame: At 6 months
measure: Time to progression
timeFrame: Time from study registration to disease progression per RECIST 1.1 and per PSMA PET/CT, assessed up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Nguyen H. Tran, MD
role: PRINCIPAL_INVESTIGATOR
References: