Hepatocellular Carcinoma Imaging Using PSMA PET/CT

Study Overview
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Brief Summary
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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
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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

Official Title
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Hepatocellular Carcinoma Imaging Using PSMA PET/CT - a Prospective Pilot Trial

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: 18F-DCFPyL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-DCFPyL<br>Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL | Drug: 18F-DCFPyL<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, PSMA, 18F-DCFPyL