TULIP ReTrain Study

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

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Multiparametric ultrasound with contrast (Sonovue and Optison)

Study type: Interventional

Funder types: Other

Identifiers

NCT06974539

NL-009343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 212 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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212 participants in 1 patient group

Multiparametric ultrasound with contrast (Sonovue and Optison)

Other group

Description:

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

Treatment:

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