Integrating Quantitative MRI and Artificial Intelligence to Improve Prostate Cancer Classification

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

This study evaluates how new magnetic resonance imaging (MRI) and artificial intelligence techniques improve the image quality and quantitative information for future prostate MRI exams in patients with suspicious of confirmed prostate cancer. The MRI and artificial intelligence techniques developed in this study may improve the accuracy in diagnosing prostate cancer in the future using less invasive techniques than what is currently used.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male patients 18 years of age and older

Clinical suspicion of prostate cancer or biopsy-confirmed prostate cancer

Undergone or undergoing multi-parametric 3 T prostate MRI at the University of California at Los Angeles (UCLA)

Ability to provide consent

Disqualifiers

Contraindications to MRI (e.g., cardiac devices, prosthetic valves, severe claustrophobia)

Contraindications to gadolinium contrast-based agents other than the possibility of an allergic reaction to the gadolinium contrast-based agent

Prior radiotherapy

Trial population

Patients at the University of California, Los Angeles (UCLA) who may have already undergone 3 T prostate multi-parametric MRI or were referred for 3 T multi-parametric prostate MRI prior to biopsy or radical prostatectomy.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 3 Tesla Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo 3T MRI

  • Electronic Health Record Review

    Other intervention

    Medical charts are reviewed

Treatment groups

275 Participants
are divided into 1 treatment group
Group A: Observational (electronic health record review, 3 T MRI)2 interventions

Trial outcomes

Primary outcomes

1

Development of quantitative dynamic contrast (DCE)-enhanced-magnetic resonance imaging (MRI) analysis techniques

Both transfer constant (Ktrans) and rate constant (Kep) from normal prostate tissue will be evaluated for the inter-scanner variability. Pairwise dissimilarities between distributions will be estimated by computing the Kolmogorov-Smirnov statistic, defined as the maximum difference between the empirical distribution functions over the range of the parameter, using 200 cases for each of three MRI scanners. The mean of these pairwise dissimilarities between scanners will be computed to quantify the overall discrepancy of each DCE-MRI model. Construction of a 95% confidence interval for the difference in the mean discrepancies using the nonparametric bootstrap will be done to compare this mean discrepancy between DCE-MRI models. 10,000 bootstrap samples will be generated by sampling patients with replacement, stratifying by the scanner. Will conclude that the proposed DCE-MRI model has a reduced inter-scanner variability if the 95% confidence interval is entirely less than zero.

Time frame
Up to 5 years
2

Development of diffusion weighted imaging (DWI) methods that reduce prostate geometric distortion

Differences between rectangular field of view-ENCODE and standard DWI in terms of the prostate Dice's similarity coefficient (primary outcome) and apparent diffusion coefficient consistency will be compared.

Time frame
Up to 5 years
3

Development of multi-class deep learning models

The overall performance of FocalNet and Prostate Imaging Reporting \& Data System version 2 will be compared in terms of area under the curve. Comparison between area under the curves will be performed using DeLong's test. Will also include the comparison between FocalNet and baseline deep learning methods (U-Net and Deeplab without focal loss \[FL\] and mutual finding loss \[MFL\]) to characterize the advantages of using FL and MFL with the same study cohort. For each of these approaches, an optimal cut-point for classification of clinically significant prostate cancer will be identified by maximizing Youden's J (= sensitivity + specificity - 1) and will report sensitivity, specificity and 95% confidence intervals based on the selected cut-point.

Time frame
Up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator