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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Prostate Cancer Without an Endorectal Coil

Conditions
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Prostate Adenocarcinoma, Prostate Carcinoma

Intervention / Treatment
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* Procedure: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening (3D MRI)<br>Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time. | Procedure: Magnetic Resonance Imaging<br>* Undergo 3D MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To be assessed with scoring of quantitative image metrics in regions of prostate cancer and benign tissue | 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. | through study completion, an average of 1 year |