Hepatocellular Carcinoma Imaging Using PSMA PET/CT (HepaSMART)

Hepatocellular Carcinoma Imaging Using PSMA PET/CT - a Prospective Pilot Trial

The purpose of the research is to evaluate the use of a PSMA PET/CT (Prostate Specific Membrane Antigen Positron Emission Tomography/Computerized Tomography) scan in the diagnosis of HCC (hepatocellular carcinoma) and comparing it to standard scanning techniques with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging).

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: 18F-DCFPyL

Detailed Description

A total of 30 patients will be recruited in this prospective pilot study who have HCC on imaging criteria (LI-RADS 5) for surgical resection, or patients with indeterminate liver lesions (LI-RADS 3 or 4) planned for liver biopsy. 18F-DCFPYL PSMA PET/CT will be performed prior to the planned surgery or liver biopsy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Melbourne, Victoria, Australia
      • The Royal Melbourne Hospital
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female aged 18 years or older at screening
• Has provided written informed consent for participation in the study
• Must have risk factors for HCC e.g. cirrhosis, chronic hepatitis B infection with or without cirrhosis
• Patients with liver lesions ≥1 cm suspicious for HCC but with indeterminate features on CT and MRI meeting LI-RADS 3 or 4 criteria planned for biopsy, OR patients with liver lesions diagnostic of HCC based on CT or MRI meeting LI-RADS 5 criteria planned for surgical resection
• Patients must be willing and able to comply with the protocol and procedures for the duration of the study
• Patients must be available for follow-up

Exclusion Criteria:

• Abdominal surgery or radiotherapy to the abdomen within <4 weeks of registration. Patients must have recovered from any effects of any major surgery
• Uncontrolled intercurrent illness that is likely to impede participation and or compliance
• Any history of prostate cancer or elevated PSA level for male patients
• Other malignancies unless curatively treated with no evidence of disease within previous 3-years other than adequately treated non-melanoma skin cancer or melanoma in situ
• Participation in another clinical study with an investigational product or another systemic cancer therapy administered in the last 4 weeks
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the study
• Women who are pregnant or lactating
• Cirrhosis due to congenital hepatic fibrosis, vascular disorders (e.g. Budd-Chiari syndrome) or cardiac cirrhosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-DCFPyL; Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL	Drug: 18F-DCFPyL; 18F-DCFPyL will be administered with a single dose of 3.5 MBq per kg (2-4 MBq per kg), maximum 400 MBq), administered as a slow (over 30 seconds) intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
True Positive Rate per patient	The probability that HCC is present when the PSMA-PET/CT test result is positive on a per patient basis.	6 months
True Negative Rate per patient	The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per patient basis.	6 months
True Positive Rate per lesion	The probability that HCC is present when the PSMA-PET/CT test result is positive on a per lesion basis.	6 months
True Negative Rate per lesion.	The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per lesion basis.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSMA uptake	Qualitative uptake of PSMA measured on a per lesion basis.	6 months
Maximum standard uptake value	Maximum standard uptake value of lesions on PSMA PET/CT.	6 months
CT LIRADS (Liver Imaging Reporting and Data System) Score	LI RADS Score for CT lesions.	6 months
PSMA expression.	Expression of PSMA per lesion.	6 months
GLUT-1 expression	Expression of GLUT 1 per lesion.	6 months

Collaborators and Investigators

• Sponsor: Peter MacCallum Cancer Centre, Australia

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2021
• Primary Completion (Estimated): March 8, 2026
• Study Completion (Estimated): September 8, 2026

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 13, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: PSMA; Hepatocellular carcinoma; 18F-DCFPyL
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: HREC/62461/PMCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No