TULIP ReTrain Study

NCT ID: NCT06974539

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Multiparametric ultrasound with contrast (Sonovue and Optison)

Diagnostic test: Multiparametric ultrasound with contrast (Sonovue and Optison)

Group Type OTHER

Multiparametric ultrasound with contrast (Sonovue and Optison)

Intervention Type DIAGNOSTIC_TEST

Participants will receive 3D mpUS using both Sonovue and Optison contrast agents during a single transrectal imaging session.

Interventions

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Multiparametric ultrasound with contrast (Sonovue and Optison)

Participants will receive 3D mpUS using both Sonovue and Optison contrast agents during a single transrectal imaging session.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Angiogenesis Analytics

INDUSTRY

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Harrie P. Beerlage

Prof. Dr. H.P. Beerlage

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jorg Oddens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

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Amsterdam UMC

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Stijn van den Bosch, MD

Role: CONTACT

+31646310728

Daniel van den Kroonenberg, MD

Role: CONTACT

+31639345375

Facility Contacts

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Stijn van den Bosch, MD

Role: primary

+31646310728

References

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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.

Reference Type BACKGROUND
PMID: 40175990 (View on PubMed)

van 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.

Reference Type BACKGROUND
PMID: 39050912 (View on PubMed)

van 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.

Reference Type BACKGROUND
PMID: 12431818 (View on PubMed)

Jager 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.

Reference Type BACKGROUND
PMID: 34324383 (View on PubMed)

Related Links

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https://angiogenesisanalytics.com/

Angiogenesis Analytics - cooperation partner

Other Identifiers

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NL-009343

Identifier Type: -

Identifier Source: org_study_id

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