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Clinical Trials/NCT00831142
NCT00831142Active, not recruitingNot Applicable

Characterization of Prostate Cancer With 3T MR

Beth Israel Deaconess Medical Center1 site in 1 country236 target enrollmentStarted: June 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
236
Locations
1

Study Overview

Brief Summary

The long-term goal of this proposal is to provide a pre-treatment evaluation that can assist in the rational selection of patients to undergo appropriate and definitive therapy for prostate cancer. In so doing, it may be possible to further improve the numbers and percentage of cancer patients who receive effective therapy that will cure the disease and maximize their quality of life following therapy.

  • Aim 1: To evaluate the accuracy of T2W MRI, DCE-MRI and their combined data for staging prostate cancer.
  • Aim 2: To evaluate the accuracy of MRI in determining tumor volume in the prostate gland.
  • Aim 3: To evaluate the accuracy of MRI in grading prostate cancer.

Detailed Description

In our laboratory we have combined the use of new 3T clinical magnetic resonance (MR) technology, dynamic-contrast enhancement (DCE), and a unique endorectal-coil (ERC) probe in order to non-invasively obtain images of the prostate gland with higher signal-to-noise resolution and better spectral dispersion than has been previously achieved. This imaging strategy acquires higher-resolution images with smaller voxel sizes than has been possible with prior MR technology and more comprehensive tissue sampling compared to other pre-surgical assessments. This methodology should make it feasible to assess prostate-tissue morphology and additional features of prostate cancer such as tissue metabolism, tissue kinetics, and the vascular microenvironment, and thus provide a non-invasive tool to: 1) detect extra-capsular spread, 2) detect specific areas within the prostate that harbor cancer, 3) determine the aggressiveness of the cancer and 4) direct biopsy and treatment specifically to diseased areas.

In order to prospectively validate these goals we will recruit successive patients who have been scheduled for prostate removal to participate to our protocol. Each patient will be studied with an ERC MRI at 3T using T2-weighted (T2W) imaging, DCE 3D T1-weighted imaging and MR spectroscopy (MRS). A pathologist using whole mount preparations will independently analyze each patient's prostate specimen. The whole mount data will be used as the standard against which we will compare the observations and data obtained from the 3T MRI findings.

Aim 1: To evaluate the accuracy of T2W MRI, DCE-MRI and their combined data for staging prostate cancer.

Supplementing T2W imaging with the high-resolution capability of 3TMR, we will apply standard morphologic criteria used at 1.5T to determine the presence or absence of extracapsular extension (ECE) of disease. The possible incremental value of high spatial resolution, dynamic contrast-enhanced data will be investigated. MRI results will be compared to ECE determination at whole-mount pathology.

Aim 2: To evaluate the accuracy of MRI in determining tumor volume in the prostate gland.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Alsop

Director of MR Research

Beth Israel Deaconess Medical Center

Study Sites (1)

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