Hepatocellular Carcinoma Imaging Using PSMA PET/CT

NCT05095519 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: HREC/62461/PMCC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; PSMA; 18F-DCFPyL

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• PSMA uptake

  6 months

• Maximum standard uptake value

  6 months

• CT LIRADS (Liver Imaging Reporting and Data System) Score

  6 months

• PSMA expression.

  6 months

• GLUT-1 expression

  6 months

Study Arms (1)

18F-DCFPyL

EXPERIMENTAL

Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL

Drug: 18F-DCFPyL

Interventions

18F-DCFPyL DRUG

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

18F-DCFPyL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead

Study Sites (4)

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 27, 2021
• Study Start: September 8, 2021
• Primary Completion: March 8, 2026
• Study Completion (Estimated): September 8, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

AU (4)