An Investigational Scan (MRI With Dixon Based Sequences) in Detecting Prostate Cancer

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

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-25

Study Completion Date

2027-02-02

Brief Summary

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This trial studies the use of magnetic resonance imaging (MRI) with Dixon based imaging sequences in detecting prostate cancer. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Researchers hope to learn if using a modified MRI scan technique with Dixon based imaging sequencing will help to produce better images of prostate cancer than the standard of care MRI scan technique.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Evaluate prospectively the accuracy of Dixon based sequences in detection of intraprostatic tumor nodules.

II. Determine the sensitivity, specificity, positive and negative predictive value of Dixon based sequences in assessment of extraprostatic tumor extension and lymph node involvement.

SECONDARY OBJECTIVES:

I. Compare the accuracy of Dixon based sequences versus multiparametric diffusion weighted imaging including diffusion tensor imaging in tumor detection and extraprostatic extension.

II. Compare the accuracy of Dixon based sequences in detection of transition zone tumors.

III. Determine the optimal scanning parameters for Dixon based sequences in the imaging of prostate adenocarcinoma.

OUTLINE:

Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.

Conditions

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Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (standard MRI, Dixon MRI)

Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.

Group Type EXPERIMENTAL

Dixon MRI

Intervention Type PROCEDURE

Undergo Dixon MRI

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo standard MRI

Interventions

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Dixon MRI

Undergo Dixon MRI

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo standard MRI

Intervention Type PROCEDURE

Other Intervention Names

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Dixon Fat-Suppression MRI Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging

Eligibility Criteria

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Inclusion Criteria

* Biopsy proven prostate cancer patients who are scheduled to undergo prostatectomy.
* Patient who is scheduled to have a clinically indicated staging endorectal prostate MRI exam.
* Patients who have signed their informed consent form to undergo the study.

Exclusion Criteria

* Known prior hormone ablation or radiation therapy (pelvic or prostate).
* Patients who do not want to undergo prostatectomy and prefer other therapy or surveillance.
* Contraindication to conventional MR imaging (e. g. metal implants, pace maker, etc.).

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No