Clinical trial · Interventional
TULIP ReTrain Study
Optimization of PCaVision: A Prospective Study for CAD-based Detection of Clinically Significant Prostate Cancer Using mpUS and Contrast Agents
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiparametric ultrasound with contrast (Sonovue and Optison) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Multiparametric ultrasound with contrast (Sonovue and Optison)
- description
- Diagnostic test: Multiparametric ultrasound with contrast (Sonovue and Optison)
- interventionNames
- Diagnostic Test: Multiparametric ultrasound with contrast (Sonovue and Optison)
Primary outcomes (1)
- measure
- Sensitivity and Specificity of PCaVision Algorithm (Sonovue and Optison) Compared to Histopathology
- timeFrame
- From baseline imaging to histopathology report (typically within 2-4 weeks post-surgery)
- description
- 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 outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDJager A, Zwart MJ, Postema AW, van den Kroonenberg DL, Zwart W, Beerlage HP, Oddens JR, Mischi M. Development and validation of a framework for registration of whole-mount radical prostatectomy histopathology with three-dimensional transrectal ultrasound. BMC Urol. 2025 Apr 3;25(1):73. doi: 10.1186/s12894-025-01736-4. PMID 40175990
- BACKGROUNDvan den Kroonenberg DL, Jager A, Garrido-Utrilla A, Reitsma JB, Postema AW, Beerlage HP, Oddens JR. Clinical Validation of Multiparametric Ultrasound for Detecting Clinically Significant Prostate Cancer Using Computer-Aided Diagnosis: A Direct Comparison with the Magnetic Resonance Imaging Pathway. Eur Urol Open Sci. 2024 Jul 1;66:60-66. doi: 10.1016/j.euros.2024.06.012. eCollection 2024 Aug. PMID 39050912
- BACKGROUNDvan Moorselaar RJ, Voest EE. Angiogenesis in prostate cancer: its role in disease progression and possible therapeutic approaches. Mol Cell Endocrinol. 2002 Nov 29;197(1-2):239-50. doi: 10.1016/s0303-7207(02)00262-9. PMID 12431818
- BACKGROUNDJager A, Vilanova JC, Michi M, Wijkstra H, Oddens JR. The challenge of prostate biopsy guidance in the era of mpMRI detected lesion: ultrasound-guided versus in-bore biopsy. Br J Radiol. 2022 Mar 1;95(1131):20210363. doi: 10.1259/bjr.20210363. Epub 2021 Jul 29. PMID 34324383