prostate cancer prostate cancer
Conditions
Interventions
Investigational Product: The study evaluates the PCaVision system, a computer-aided diagnostic (CAD) algorithm designed to detect and localize csPCa using 3D multiparametric ultrasound (mpUS) images.I
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: be malehave an age of 18 years or olderhave signed the informed consent be scheduled for RP (cohort 1)Diagnostic prostate MRI with PI-RADS = 2 (cohort 2)
Exclusion criteria
Exclusion criteria: a patient history with a cardiac right-to-left shunt.allergic to sulphur hexafluoride, perflutren or any of the other ingredients of the ultrasound contrast agentcurrent treatment with dobutamineknown severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension or respiratory distress syndromeany (further) contraindication to undergo 3D mpUS imagingincapable of understanding the language in which the patient information is givenPlanned use NeuroSAFE technique during RP surgery (Dinneen et al., 2022)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the study is to gather sufficient data to train the PCaVision algorithm for detecting csPCa with the use of Optison and acquiring data with the new version of the ultrasound machine. Accurate lesion localization will be evaluated by correlating the algorithm's findings with the RP histopathology results, measured by sensitivity and specificity for csPCa on patient and voxel level. Cohort 2 (assumed negative patients) will be used to assess the specificity for csPCa at patient level. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the diagnostic performance of the PCaVision algorithm in external validation by assessing the sensitivity for csPCa at both voxel and patient levels, comparing SonoVue and Optison versions against the ground truth. | — |
Countries
Netherlands
Contacts
Public ContactS.M. van den Bosch
Amsterdam UMC
Outcome results
None listed