# Addition of F18-Piflufolastat PET/CT to Cross-Sectional Imaging for the Staging and Management of Hepatocellular Carcinoma

> **NIH VA I01** · MIAMI VA HEALTH CARE SYSTEM · 2024 · —

## Abstract

As the sixth most common cancer and the third most common cause of cancer death accounting
for 800,000 deaths a year globally, hepatocellular carcinoma (HCC) is a challenging malignancy
to diagnose and manage, with an overall 5-year survival of only 20%. HCC has a rising incidence
and is the leading cause of death among patients with cirrhosis. Since liver cancer is found more
frequently among men, and death related to liver cancer is about 3 times greater in men, the
United States veteran population is at particular risk. Veterans have a higher incidence of
nonalcoholic fatty liver disease, alcohol associated liver disease and viral hepatitis, which are the
most common risk for HCC. The threat of HCC persists despite the successful cure of hepatitis C
infection. The VA Health Care System is the largest provider in the US for the treatment of liver
disease and liver cancer, thus making advances in detection, diagnosis, radiogenomics and the
identification of prognostic indicators of liver cancer an important component of the VA’s Precision
Oncology initiative.
 Prostate-specific membrane antigen (PSMA) is upregulated in an estimated 91% of HCC.
Preliminary studies have shown that a novel PSMA-targeted PET (PSMA PET), which is currently
approved and utilized for the evaluation of prostate cancer, is highly sensitive in the detection of
HCC. In this proposal, we delineate a plan to consider and demonstrate the utility of PSMA PET
scans in three groups of veterans: those undergoing surveillance for HCC, treatment naïve
patients who are newly diagnosed with HCC, and patients previously treated for HCC being
evaluated for treatment response. By evaluating PSMA PET in these specific patient populations,
we intend to improve the accuracy of diagnosis and staging of HCC, and avoid futile locoregional
therapies to patients with metastatic HCC. By improving the diagnosis and staging of HCC with
PSMA-PET the ultimate aim of this study is improved overall survival. Specifically, the following
parameters will be evaluated: 1. the utility of PSMA PET in improving the diagnosis of HCC within
indeterminate nodules (LIRADS; LR3 and LR4 lesions) in patients with cirrhosis undergoing
surveillance, 2. the addition of PSMA PET in improving the accuracy of HCC staging among
treatment naïve patients compared to CT/MRI, 3. the role of PSMA PET in improving the
assessment of treatment response in HCC patients treated with locoregional therapy (LRT).
 We expect that PSMA PET will identify locoregional or distant HCC metastatic lesions not
detected by CT/MRI, thus altering BCLC staging and management. We also anticipate that the
lack of uptake of PSMA may reliably detect the complete response of HCC after LRT, and that
residual activity will correlate with viable tumor. PSMA PET will be performed concurrently with
CT/MRI, and staging and response to HCC treatment will be compared between that with CT/MRI,
and CT/MRI plus PSMA PET. Data gathered by this observational clinic...

## Key facts

- **NIH application ID:** 10805629
- **Project number:** 1I01CX002654-01A1
- **Recipient organization:** MIAMI VA HEALTH CARE SYSTEM
- **Principal Investigator:** BINU JOHN
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2024-04-01 → 2028-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10805629

## Citation

> US National Institutes of Health, RePORTER application 10805629, Addition of F18-Piflufolastat PET/CT to Cross-Sectional Imaging for the Staging and Management of Hepatocellular Carcinoma (1I01CX002654-01A1). Retrieved via AI Analytics 2026-06-05 from https://api.ai-analytics.org/grant/nih/10805629. Licensed CC0.

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