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Hepatocellular Carcinoma Imaging Using PSMA PET/CT
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-09-08
Primary completion: 2024-03-08
Study completion finish: 2024-09-08
Study type
DIAGNOSTIC
Phase
PHASE2
Trial ID
NCT05095519
Intervention or treatment
DRUG: 18F-DCFPyL
Conditions
- • Hepatocellular Carcinoma
Find a site
Closest Location:
Austin Health
Research sites nearby
Select from list below to view details:
Austin Health
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: 18F-DCFPyL
| DRUG: 18F-DCFPyL
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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. | 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. | 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. | 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. | 6 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
PSMA uptake | Qualitative uptake of PSMA measured on a per lesion basis. | 6 months |
Maximum standard uptake value | Maximum standard uptake value of lesions on PSMA PET/CT. | 6 months |
CT LIRADS (Liver Imaging Reporting and Data System) Score | LI RADS Score for CT lesions. | 6 months |
PSMA expression. | Expression of PSMA per lesion. | 6 months |
GLUT-1 expression | Expression of GLUT 1 per lesion. | 6 months |
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