Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Screening Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Prostate Carcinoma; Prostate Adenocarcinoma
• Interventions: Procedure: Magnetic Resonance Imaging

• Registration Number: NCT05055843
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This clinical trial studies examines a 3D magnetic resonance imaging (MRI) compared to standard MRI imaging techniques in screening patients with prostate cancer. Diagnostic procedures, such as MRI, may help find and diagnose prostate cancer. Computer systems that allow doctors to create a 3-dimensional (3-D) picture of the tumor may help in planning.

Detailed Description

PRIMARY OBJECTIVE:

I. To determine whether the image quality of the novel 3-dimensional (3D) T2-weighted imaging (T2W) synthetic imaging technique without endorectal coil is comparable to the 2-dimensional (2D) T2W imaging technique without endorectal coil.

SECONDARY OBJECTIVE:

I. To evaluate the qualitative diagnostic quality of the T2W images provided by the novel 3D technique, as determined by subjective scoring by experienced readers.

EXPLORATORY OBJECTIVE:

I. To investigate the feasibility of novel 3D synthetic imaging and multi-spin parameter mapping technique of prostate for the detection of clinically significant prostate cancer (csPCa).

OUTLINE:

Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-21
• Study Start: 2021-08-10
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 33

Inclusion Criteria

• Male, age >= 18
• Untreated, biopsy-proven with intermediate and high-risk adenocarcinoma of the prostate
• Patient is being considered for curative-intent treatment with radical prostatectomy
• Patient has provided written informed consent for participation in this trial
• Patient should be eligible for scanning on a 3T magnet

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Exclusion Criteria

• Low-risk adenocarcinoma of prostate
• Any prior therapy for prostate cancer
• A history of other active malignancy within the last 2 years
• Prostate cancer with significant sarcomatoid, spindle cell, or neuroendocrine small cell components
• Cardiac pacemaker
• Orthopedic hardware in the pelvis and spine
• Claustrophobia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening (3D MRI)	Magnetic Resonance Imaging	Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time.

Primary Outcome Measures

Name	Time	Method
To be assessed with scoring of quantitative image metrics in regions of prostate cancer and benign tissue	through study completion, an average of 1 year	Comparing the 2-dimensional (2D) T2W imaging technique without endorectal coil.; Scored from 1 to 5 with PI-RADS 1 indicating that csPCa is highly unlikely whereas a PI-RADS 5 score indicates that csPCa is highly likely to be present.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States