Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods

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

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to determine the ability of several new MRI techniques (MR elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo MRI will also be conducted on the prostate specimen to obtain high resolution imaging correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators hypothesize that the addition of these three techniques will increase the accuracy, sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.

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Detailed Description

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Conditions

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Prostate Cancer

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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Single arm study

Group Type EXPERIMENTAL

MRI with gadofosveset and MR elastography

Intervention Type OTHER

Interventions

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MRI with gadofosveset and MR elastography

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy

Exclusion Criteria

* unable to give informed consent
* contraindication to MRI or MRI contrast agent
* claustrophobia
* renal impairment
* prior hormonal or radiation therapy for prostate cancer
* active prostatitis
* moderate to severe rectal inflammation
* previous rectal surgery
* prostate biopsy within 4 weeks of planned MRI

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No