Hepatocellular Carcinoma Imaging Using PSMA PET/CT

NCT ID: NCT05095519

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-08
• Study Completion Date: 2026-09-08

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).

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-DCFPyL

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

Group Type: EXPERIMENTAL

18F-DCFPyL

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St Vincent's Hospital

Fitzroy, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

HREC/62461/PMCC

Identifier Type: -

Identifier Source: org_study_id