Hepatocellular Carcinoma Imaging Using PSMA PET/CT

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).

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

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