Integrating Quantitative MRI and Artificial Intelligence to Improve Prostate Cancer Classification

NCT ID: NCT04765150

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2027-06-01

Brief Summary

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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

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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.

Conditions

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Prostate Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Observational (electronic health record review, 3 T MRI)

RETROSPECTIVE: Patients' medical records are reviewed.

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

3 Tesla Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo 3T MRI

Electronic Health Record Review

Intervention Type OTHER

Medical charts are reviewed

Interventions

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3 Tesla Magnetic Resonance Imaging

Undergo 3T MRI

Intervention Type PROCEDURE

Electronic Health Record Review

Medical charts are reviewed

Intervention Type OTHER

Other Intervention Names

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3 Tesla MRI 3T MRI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung H Sung, PhD

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nashla Barroso

Role: CONTACT

(310) 794-7952

Facility Contacts

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Nashla Barroso

Role: primary

(310) 794-7952

Other Identifiers

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NCI-2021-00373

Identifier Type: REGISTRY

Identifier Source: secondary_id

19-002202

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA248506

Identifier Type: NIH

Identifier Source: secondary_id

View Link

441480-KS-29447

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

19-002202

Identifier Type: -

Identifier Source: org_study_id

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