Improving Prostate Lesion Classification and Development of a PI-RADS 3 Classifier
November 2, 2023 updated by: Dr. Panagiota Manava, Paracelsus Medical University
Improving Prostate Lesion Classification and Diagnostic Accuracy Using Machine Learning: A Comprehensive Evaluation and Development of a PI-RADS 3 Classifier
The investigators propose an AI methodology combining machine learning, histological results and expert image interpretation for the development of a PI-RADS 3 classifier.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
173
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nuernberg, Germany
- Department of Radiology and Nuclear Medicine, Klinikum Nuernberg, Paracelsus Medical University, Germany
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
the study population will be patients of a primary care clinic
Description
Inclusion Criteria:
- Only patients with a clinical indication for mp prostate MRI will be included in this prospective study.
- No allergies to GBCA
Exclusion Criteria:
1. Contraindications for MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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experimental
experimental: patients with a condition
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control group
control group: patients without condition
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Normalized Quantitative Signal - Intensity - Measurements with Region of Interest drawn in specific T2-weighted axial MRI Images
Time Frame: through study completion, an average of 3 years
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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.
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through study completion, an average of 3 years
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Quantitative Signal - Intensity - Measurements with Region of Interest in specific in Apparent diffusion coefficient (ADC) axial MRI Images
Time Frame: through study completion, an average of 3 years
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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
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through study completion, an average of 3 years
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Quantitative Signal - Intensity - Measurements with Region of Interest in specific in high b-value (800, 1500, 4000) axial MRI Images
Time Frame: through study completion, an average of 3 years
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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
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through study completion, an average of 3 years
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Signal - Intensity - Measurements with Region of Interest in specific dynamic contrast enhanced (DCE) MRI Images
Time Frame: through study completion, an average of 3 years
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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.
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through study completion, an average of 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael M. Lell, Prof. Dr. med., Department of Radiology and Nuclear Medicine, Klinikum Nuernberg, Paracelsus Medical University, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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 Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18.
- 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.eururo.2015.08.052. Epub 2015 Oct 1.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
August 24, 2023
Study Registration Dates
First Submitted
August 24, 2023
First Submitted That Met QC Criteria
November 2, 2023
First Posted (Actual)
November 3, 2023
Study Record Updates
Last Update Posted (Actual)
November 3, 2023
Last Update Submitted That Met QC Criteria
November 2, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI_Prostate_1_KNN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.