Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
18F-DCFPyL · 1 trial · 1 indication
The probability that HCC is present when the PSMA-PET/CT test result is positive on a per patient basis.
The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per patient basis.
The probability that HCC is present when the PSMA-PET/CT test result is positive on a per lesion basis.
The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per lesion basis.
| Arm | Type | Description |
|---|---|---|
| 18F-DCFPyL | EXPERIMENTAL | Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL |
| Name | Type | Description |
|---|---|---|
| 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 |
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...