Hepatocellular Carcinoma Imaging Using PSMA PET/CT

• Status: Recruiting
• Trial end date: 2023-09-08
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter MacCallum Cancer Centre, Australia

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