Hepatocellular Carcinoma Imaging Using PSMA PET/CT
- Registration Number
- NCT05095519
- Lead Sponsor
- Peter MacCallum Cancer Centre, Australia
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-DCFPyL 18F-DCFPyL Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL
- Primary Outcome Measures
Name Time Method True Positive Rate per lesion 6 months The probability that HCC is present when the PSMA-PET/CT test result is positive on a per lesion basis.
True Negative Rate per lesion. 6 months The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per lesion basis.
True Positive Rate per patient 6 months The probability that HCC is present when the PSMA-PET/CT test result is positive on a per patient basis.
True Negative Rate per patient 6 months The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per patient basis.
- Secondary Outcome Measures
Name Time Method PSMA expression. 6 months Expression of PSMA per lesion.
GLUT-1 expression 6 months Expression of GLUT 1 per lesion.
PSMA uptake 6 months Qualitative uptake of PSMA measured on a per lesion basis.
Maximum standard uptake value 6 months Maximum standard uptake value of lesions on PSMA PET/CT.
CT LIRADS (Liver Imaging Reporting and Data System) Score 6 months LI RADS Score for CT lesions.
Trial Locations
- Locations (4)
St Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
The Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia