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NCT Number: NCT04765150

Integrating Quantitative MRI and Artificial Intelligence to Improve Prostate Cancer Classification

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Kyung H. Sung, PhD

PRINCIPAL_INVESTIGATOR

Nashla Barroso

CONTACT

[email protected]

310-794-7952

About this study

PRIMARY OBJECTIVES:

I. To develop and evaluate quantitative dynamic contrast-enhanced (DCE)-MRI analysis techniques that minimize patient- and scanner-specific variabilities in the calculation of quantitative parameters.

II. To develop and evaluate diffusion weighted imaging (DWI) methods that reduce prostate geometric distortion due to patient- and scanner-specific susceptibility and eddy current effects.

III. To develop and evaluate multi-class deep learning models that systematically integrate quantitative multi-parametric (mp)-MRI features for accurate detection and classification of clinically significant prostate cancer (csPCa).

OUTLINE:

RETROSPECTIVE: Patients' medical records are reviewed.

PROSPECTIVE: Patients undergo additional 3 Tesla (T) MRI imaging over 30 minutes before, during, or after their standard of care 3T MRI for a total of 1.5 hours.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

3 Tesla Magnetic Resonance Imaging

Procedure

Undergo 3T MRI

Other names: 3 Tesla MRI, 3T MRI

Electronic Health Record Review

Other

Medical charts are reviewed

Primary outcomes

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

    Time frame: Up to 5 years

    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.

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

    Time frame: Up to 5 years

    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.

  3. Development of multi-class deep learning models

    Time frame: Up to 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nashla Barroso

CONTACT

[email protected]

(310) 794-7952

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Feb 21, 2021
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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