Study details: Hepa-SMART

Full title:
Hepatocellular Carcinoma Imaging using PSMA PET/CT – a Prospective Pilot Trial

Lead Investigator:
Nicholas Hannah

Lead Investigator e-mail:
Nicholas.Hannah2@mh.org.au

Principle Investigator:
Dr Siddharth Sood /Dr Grace Kong

Study description:
Hepatocellular carcinoma (HCC) accounts for 8-% of all primary liver cancers. Early diagnosis allows for potential curative therapy, but advanced disease and extra-hepatic spread have a poor prognosis. Positron emission tomography (PET) has traditionally demonstrated poor sensitivity for HCC. Recently, radio-labelled prostate-specific membrane antigen (PSMA) has shown promise in imaging of HCC. We aim to further evaluate 18F-PSMA PET/CT in the imaging of HCC. This is a Prospective single-arm, multicentre, pilot study to determine the overall diagnostic performance of PSMA PET/CT for detecting HCC.

We are recruiting 30 patients in total among two trial groups, group 1: Patients with suspected but indeterminate liver lesions (LIRADS 3 or 4) on conventional imaging requiring a liver biopsy (20 patients), and group 2: Patients with HCC diagnosed with typical radiological findings (LIRADS 5) for planned surgical resection with curative intent (10 patients). Specific inclusion criteria include: 18 years or older, able to consent and available for follow-up and meet the above criteria of group 1 or 2. Specific exclusion criteria: Abdominal surgery or radiotherapy within 4 weeks, uncontrolled intercurrent illness impairing participation, history of prostate cancer or elevated PSA level, Other malignancy unless curative treated in previous 3 years, Substance abuse that would interfere with trial protocol, woman that are lactating, cirrhosis due to congenital hepatic fibrosis, vascular disorders or cardiac cirrhosis.

Primary objectives include: Determining the diagnostic performance by positive and negative predictive values PSMA PET/CT for detecting HCC in each patient group and to determine the diagnostic accuracy of PSMA PET/CT in detecting HCC for patients with suspected liver HCC planned for biopsy.

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