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Artificial Intelligence and Radiologists at Prostate Cancer Detection in MRI: The PI-CAI Challenge

NCT05489341 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10207

Last updated 2023-11-18

No results posted yet for this study

Summary

The PI-CAI challenge aims to validate the diagnostic performance of artificial intelligence (AI) and radiologists at clinically significant prostate cancer (csPCa) detection/diagnosis in MRI, with respect to histopathology and follow-up (≥ 3 years) as reference. The study hypothesizes that state-of-the-art AI algorithms, trained using thousands of patient exams, are non-inferior to radiologists reading bpMRI. As secondary end-points, it investigates the optimal AI model for csPCa detection/diagnosis, and the effects of dynamic contrast-enhanced imaging and reader experience on diagnostic accuracy and inter-reader variability.

Conditions

Interventions

DIAGNOSTIC_TEST

Histopathology and Magnetic Resonance Imaging with Follow-Up

Reference standard establishes histologically-confirmed (ISUP ≥ 2) cases of csPCa as positives, and histopathology- (ISUP ≤ 1) or MRI- (PI-RADS ≤ 2) with follow-up (≥ 3 years) confirmed cases of indolent PCa or benign tissue as negatives.

DIAGNOSTIC_TEST

Histopathology and Magnetic Resonance Imaging

Reference standard establishes histologically-confirmed (ISUP ≥ 2) cases of csPCa as positives, and histopathology- (ISUP ≤ 1) or MRI- (PI-RADS ≤ 2) confirmed cases of indolent PCa or benign tissue as negatives.

Sponsors & Collaborators

  • Ziekenhuisgroep Twente

    collaborator OTHER

  • University Medical Center Groningen

    collaborator OTHER

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Henkjan Huisman, PhD · Radboud University Medical Center

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-06-01
Completion
2023-11-01

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05489341 on ClinicalTrials.gov