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Recruiting NCT04765150

Integrating Quantitative MRI and Artificial Intelligence to Improve Prostate Cancer Classification

Observational Prostate Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3 Tesla Magnetic Resonance Imaging, Electronic Health Record Review.
Who it may be relevant to
Registry conditions: Prostate Carcinoma. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Procedure 3 Tesla Magnetic Resonance Imaging
    Undergo 3T MRI
  • Other Electronic Health Record Review
    Medical charts are reviewed

Primary outcome measures

  • Development of quantitative dynamic contrast (DCE)-enhanced-magnetic resonance imaging (MRI) analysis techniques [Time frame: Up to 5 years]
  • Development of diffusion weighted imaging (DWI) methods that reduce prostate geometric distortion [Time frame: Up to 5 years]
  • Development of multi-class deep learning models [Time frame: Up to 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT04765150 · 19-002202 · NCI-2021-00373 · 19-002202 · R01CA248506 · 441480-KS-29447

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗