psma pet for the staging and management of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma (HCC)

Summary: this prospective, single-center study evaluates the clinical utility of f18-piflufolastat (psma) pet/ct when added to conventional cross-sectional imaging for patients with suspected or confirmed hepatocellular carcinoma (hcc). the study aims to determine whether psma pet/ct improves diagnostic accuracy for indeterminate liver lesions (li-rads 3 and 4), enhances staging precision in treatment-naïve patients, and provides more accurate assessment of treatment response in patients undergoing locoregional therapy (lrt). the goal is to assess how psma pet/ct may impact clinical decision-making, staging, and management of hcc across multiple stages of disease.

hepatocellular carcinoma (hcc) is the most common primary liver cancer and a leading cause of cancer-related mortality worldwide. accurate diagnosis, staging, and treatment response assessment are critical for optimal management of patients with hcc. however, conventional imaging modalities, such as contrast-enhanced ct and mri, have limitations in characterizing indeterminate liver lesions and in detecting intrahepatic or extrahepatic disease, particularly in the context of post-treatment changes. this prospective, single-center study investigates the added value of f18-piflufolastat (psma) pet/ct in the evaluation and management of patients with suspected or confirmed hcc. psma (prostate-specific membrane antigen) is a cell surface protein that, while originally characterized in prostate cancer, has demonstrated overexpression in the neovasculature of a variety of solid tumors, including hcc. f18-piflufolastat is a radiotracer that targets psma, allowing for enhanced molecular imaging. participants will undergo psma pet/ct imaging in addition to standard-of-care imaging (ct and/or mri). the study is designed to address three primary clinical questions: 1. diagnosis: does the addition of psma pet/ct improve characterization of indeterminate liver lesions (e.g., li-rads 3 or 4)? 2. staging: can psma pet/ct improve the accuracy of disease staging in treatment-naïve patients by detecting intrahepatic or extrahepatic disease not visualized on conventional imaging? 3. treatment response: in patients who have undergone locoregional therapy (lrt), does psma pet/ct provide more precise assessment of viable tumor tissue compared to standard imaging? data collected will include imaging results, histopathological confirmation when available, changes in clinical management prompted by psma pet/ct findings, and correlation with clinical outcomes. by evaluating the clinical utility of psma pet/ct across multiple phases of the disease course, this study aims to inform future diagnostic algorithms and treatment planning strategies in patients with hcc.

Eligibility criteria:
inclusion criteria: * 1. adult patients age\>18 years from the va medical system; 2. treatment-naïve patients with hcc with bclc b or c disease. exclusion criteria: * 1. patients with renal dysfunction or contrast allergy that precludes contrast enhanced cross sectional imaging; 2. patients with presence of active primary malignancy other than hcc and non-melanoma skin cancer in the past 3 years.