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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
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
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
True Positive Rate per patient
The probability that HCC is present when the PSMA-PET/CT test result is positive on a per patient basis.
Time frame: 6 months
True Negative Rate per patient
The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per patient basis.
Time frame: 6 months
True Positive Rate per lesion
The probability that HCC is present when the PSMA-PET/CT test result is positive on a per lesion basis.
Time frame: 6 months
True Negative Rate per lesion.
The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per lesion basis.
Time frame: 6 months
PSMA uptake
Qualitative uptake of PSMA measured on a per lesion basis.
Time frame: 6 months
Maximum standard uptake value
Maximum standard uptake value of lesions on PSMA PET/CT.
Time frame: 6 months
CT LIRADS (Liver Imaging Reporting and Data System) Score
LI RADS Score for CT lesions.
Time frame: 6 months
PSMA expression.
Expression of PSMA per lesion.
Time frame: 6 months
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GLUT-1 expression
Expression of GLUT 1 per lesion.
Time frame: 6 months