Ireland
--:--IST
Starting soon Not applicable

TULIP ReTrain Study

NCT06974539 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2025-07
Last updated
2025-05-16

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Multiparametric ultrasound with contrast (Sonovue and Optison)

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.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Amsterdam UMC Amsterdam Netherlands
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06974539 on ClinicalTrials.gov ↗ ← All trials in the Netherlands