Hepatocellular Carcinoma Imaging Using PSMA PET/CT (HepaSMART)

Peter MacCallum Cancer Centre, Australia

Status and phase

Enrolling

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: 18F-DCFPyL

Study type

Interventional

Funder types

Other

Identifiers

NCT05095519

HREC/62461/PMCC

Details and patient eligibility

About

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).

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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