TULIP ReTrain Study

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06974539
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 ultrasound (mpUS) with two different ultrasound contrast agents: Sonovue and Optison. Data will be collected using a commercial version of the LOGIQ E10 ultrasound machine, with full histopathological correlation in patients undergoing radical prostatectomy.

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 the LOGIQ E10 R4, a commercially available system, and using both Sonovue and Optison as contrast agents. The goal is to enhance generalizability and enable broader clinical adoption. The study includes two cohorts: patients scheduled for radical prostatectomy (for training and voxel-level validation) and patients with a negative prostate MRI (for patient-level specificity evaluation). All participants will undergo 3D transrectal mpUS with both contrast agents in a single session. Full prostate histology from RP specimens will serve as the reference standard.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Study Start: 2025-07
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 212

Inclusion Criteria

• Male ≥18 years
• Cohort 1: Histologically confirmed prostate cancer scheduled for radical prostatectomy
• Cohort 2: Negative multiparametric prostate MRI (PI-RADS ≤ 2)

Exclusion Criteria

• Severe pulmonary hypertension
• Cardiac right-to-left shunt
• Known allergy to Sonovue or Optison
• Contraindication for ultrasound contrast agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of PCaVision Algorithm (Sonovue and Optison) Compared to Histopathology	From baseline imaging to histopathology report (typically within 2-4 weeks post-surgery)	Sensitivity and specificity of the PCaVision algorithm in detecting and localizing clinically significant prostate cancer (csPCa, Gleason Grade Group ≥2) at the voxel level, based on 3D multiparametric ultrasound (mpUS) images using Sonovue and Optison, validated against full prostate histology after radical prostatectomy.

Secondary Outcome Measures

Name	Time	Method
Specificity of PCaVision in MRI-Negative Cohort	From baseline imaging to completion of image processing and analysis (within 2 weeks of scan)	Evaluation of the specificity of the PCaVision algorithm for csPCa detection at the patient level in men with a negative prostate MRI (PI-RADS ≤2), using mpUS imaging with Sonovue and Optison.
Diagnostic Performance Comparison Between Sonovue and Optison	Imaging and analysis completed within 4 weeks post-surgery	Head-to-head comparison of diagnostic performance (sensitivity, specificity, AUC) of PCaVision on mpUS scans obtained with Sonovue versus Optison, using RP histopathology as reference. Evaluated at voxel level and using simulated biopsy protocols.

Trial Locations

Locations (1)

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands