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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DCFPyL | Experimental | Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DCFPyL | Drug | 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia | ||
| Austin Health |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C572626 | 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid |
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| 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 |
| Heidelberg |
| Victoria |
| 3084 |
| Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| The Royal Melbourne Hospital | Melbourne | Victoria | Australia |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |