TULIP ReTrain Study
TULIP ReTrain
Optimization of PCaVision: A Prospective Study for CAD-based Detection of Clinically Significant Prostate Cancer Using mpUS and Contrast Agents
1 other identifier
interventional
212
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Jul 2025
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 16, 2025
May 1, 2025
1 year
May 8, 2025
May 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of PCaVision Algorithm (Sonovue and Optison) Compared to Histopathology
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.
From baseline imaging to histopathology report (typically within 2-4 weeks post-surgery)
Secondary Outcomes (2)
Specificity of PCaVision in MRI-Negative Cohort
From baseline imaging to completion of image processing and analysis (within 2 weeks of scan)
Diagnostic Performance Comparison Between Sonovue and Optison
Imaging and analysis completed within 4 weeks post-surgery
Study Arms (1)
Multiparametric ultrasound with contrast (Sonovue and Optison)
OTHERDiagnostic test: Multiparametric ultrasound with contrast (Sonovue and Optison)
Interventions
Participants will receive 3D mpUS using both Sonovue and Optison contrast agents during a single transrectal imaging session.
Eligibility Criteria
You may qualify if:
- Male ≥18 years
- Cohort 1: Histologically confirmed prostate cancer scheduled for radical prostatectomy
- Cohort 2: Negative multiparametric prostate MRI (PI-RADS ≤ 2)
You may not qualify if:
- Severe pulmonary hypertension
- Cardiac right-to-left shunt
- Known allergy to Sonovue or Optison
- Contraindication for ultrasound contrast agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amsterdam UMC
Amsterdam, Netherlands
Related Publications (4)
Jager 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: 40175990BACKGROUNDvan 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: 39050912BACKGROUNDvan 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: 12431818BACKGROUNDJager 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: 34324383BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorg Oddens, MD, PhD
Amsterdam UMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. H.P. Beerlage
Study Record Dates
First Submitted
May 8, 2025
First Posted
May 16, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 16, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared for this study because the imaging data and histopathology are linked to highly sensitive clinical records. Due to privacy concerns and the risk of re-identification, even in coded form, sharing of raw participant-level data is not planned. Data will only be used internally for algorithm development and validation under strict confidentiality agreements.