Status:
NOT_YET_RECRUITING
TULIP ReTrain Study
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Angiogenesis Analytics
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This prospective clinical study aims to retrain and validate the PCaVision AI algorithm for the detection and localization of clinically significant prostate cancer (csPCa) using multiparametric ultra...
Detailed Description
The PCaVision CAD system was initially developed using Sonovue contrast and a research-only ultrasound machine (LOGIQ E10 R3). In this study, the algorithm will be retrained using data acquired from t...
Eligibility Criteria
Inclusion
- Male ≥18 years
- Cohort 1: Histologically confirmed prostate cancer scheduled for radical prostatectomy
- Cohort 2: Negative multiparametric prostate MRI (PI-RADS ≤ 2)
Exclusion
- Severe pulmonary hypertension
- Cardiac right-to-left shunt
- Known allergy to Sonovue or Optison
- Contraindication for ultrasound contrast agents
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT06974539
Start Date
July 1 2025
End Date
December 1 2026
Last Update
May 16 2025
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, Netherlands