Improving Prostate Lesion Classification and Development of a PI-RADS 3 Classifier

Prostate Cancer Clinical Trial

Official title:

Improving Prostate Lesion Classification and Diagnostic Accuracy Using Machine Learning: A Comprehensive Evaluation and Development of a PI-RADS 3 Classifier

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06116344
• Other study ID #: AI_Prostate_1_KNN
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: August 24, 2023

Study information

• Verified date: November 2023
• Source: Paracelsus Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators propose an AI methodology combining machine learning, histological results and expert image interpretation for the development of a PI-RADS 3 classifier.

Description:

Prostate cancer is the most common carcinoma in male patients in Western industrialized countries. Multiparametric prostate MRI (mpMRI) can select patients who may be potential candidates for biopsy. In this study, the investigators present a comprehensive methodology that evaluates a multitude of AI algorithms and assesses their performance on a large and high-quality dataset, aiming to generate an efficient model and develop a PI-RADS 3 classifier. By combining the power of machine learning with the information provided by mpMRI, histopathological results as well as expert image interpretation, the investigators attempt to improve the diagnostic accuracy, which in the future my lead to more informed clinical decisions and reduce unnecessary biopsies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: August 24, 2023
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Only patients with a clinical indication for mp prostate MRI will be included in this prospective study.

2. No allergies to GBCA

Exclusion Criteria:

1. Contraindications for MRI

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Germany	Department of Radiology and Nuclear Medicine, Klinikum Nuernberg, Paracelsus Medical University, Germany	Nuernberg

Sponsors (1)

Lead Sponsor	Collaborator
Paracelsus Medical University

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Morash C. What do you do with PI-RADS-3? Can Urol Assoc J. 2021 Apr;15(4):122. doi: 10.5489/cuaj.7262. No abstract available. — View Citation

Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Repo — View Citation

Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eur — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalized Quantitative Signal - Intensity - Measurements with Region of Interest drawn in specific T2-weighted axial MRI Images	Regions of interest for quantitative signal intensity measurements will be drawn in various prostate lesions, the size of the region of interest will depend on the target structure. Image analysis will be performed on a PACS workstation. Signal intensity will be measured and normalized, therefore no units needed.	through study completion, an average of 3 years
Primary	Quantitative Signal - Intensity - Measurements with Region of Interest in specific in Apparent diffusion coefficient (ADC) axial MRI Images	Regions of interest for signal intensity measurements will be drawn in various prostate lesions, the size of the region of interest will depend on the target structure. Signal intensity will be measured and normalized in mm2/s	through study completion, an average of 3 years
Primary	Quantitative Signal - Intensity - Measurements with Region of Interest in specific in high b-value (800, 1500, 4000) axial MRI Images	Regions of interest for signal intensity measurements will be drawn in various prostate lesions, the size of the region of interest will depend on the target structure. Signal intensity will be measured and normalized in mm2/s	through study completion, an average of 3 years
Primary	Signal - Intensity - Measurements with Region of Interest in specific dynamic contrast enhanced (DCE) MRI Images	Regions of interest for signal intensity measurements will be drawn in various prostate lesions, the size of the region of interest will depend on the target structure. Signal intensity will be measured and normalized. Image analysis will be performed on a PACS workstation. The original Time inteisity curves are transformed in relative enhancement curves. Thus, they are normalized with respect to first point in time and represent the percentage increase compared to the time before contrast arrival, no units needed.	through study completion, an average of 3 years