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.
PRIMARY OBJECTIVES: I. To evaluate the feasibility and diagnostic performance of gallium Ga 68 gozetotide (68Ga PSMA)-dual contrast PET/MRI for detection and staging of hepatocellular carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. II. To identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC. OUTLINE: Patients receive 68Ga-PSMA intravenously (IV) over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
52
Undergo PET/CT
Given IV
Undergo PET/MRI
PET/MRI or PET/CT
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Number of HCC Lesions With High PSMA Uptake on Baseline 68Ga-PSMA-11 PET
Treatment-naïve hepatocellular carcinoma (HCC) lesions were evaluated qualitatively on baseline 68Ga-PSMA-11 PET. Grade 1 indicated uptake less than normal liver. Grade 2 indicated uptake equal to normal liver. Grade 3 indicated uptake greater than normal liver. Grade 4 indicated uptake greater than spleen or kidneys. High PSMA uptake was defined as grade 3 or 4. Low PSMA uptake was defined as grade 1 or 2.
Time frame: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
Semi-Quantitative 68Ga-PSMA-11 PET Standardized Uptake Value (SUV) Metrics in HCC Lesions With High PSMA Uptake
Semi-quantitative PET metrics were calculated in HCC lesions showing high qualitative PSMA uptake using gradient-based volume-of-interest segmentation. Reported metrics were maximum SUV (SUVmax) and mean SUV (SUVmean).
Time frame: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
Semi-Quantitative 68Ga-PSMA-11 PET Tumor-to-Liver Background Ratio (TBR) Metrics in HCC Lesions With High PSMA Uptake
Semi-quantitative PET tumor-to-liver background ratio (TBR) metrics were calculated in HCC lesions showing high qualitative PSMA uptake using gradient-based volume-of-interest segmentation. Reported metrics were TBRmax and TBRmean.
Time frame: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.