Expired Study
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New York, New York 10065


Purpose:

The purpose of this study is to provide physicians with additional information not available with standard imaging methods for breast disease. As part of the MRI examination ordered by your physician, a new method of analyzing the images or pictures will be used. This new method is called spectroscopy and is used routinely on other parts of the body such as the prostate and brain. Pictures produced with this sequence may look slightly different than the regular MRI pictures. Using spectroscopy data, it may be possible to distinguish benign conditions of the breast from malignant tumors and provide more precise information than can be obtained with regular MRI.


Study summary:

Our aim is to perform MR Spectroscopy (MRS) on 150 evaluable patients at the end of their routine breast MRI examination using a software package from General Electric Medical Systems Milwaukee, WI). This will add time to the routine examination but will not involve additional injections of contrast. We will analyze the spectroscopic data to determine if benign lesions can be reliably differentiated from malignant ones.


Criteria:

Inclusion Criteria: - Scheduled for diagnostic breast MRI examination or interventional procedure for a known or suspected breast lesion Exclusion Criteria: - Patients who would be normally excluded from undergoing an MRI examination: - Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field


Study is Available At:


Original ID:

03-037


NCT ID:

NCT00577915


Secondary ID:


Study Acronym:


Brief Title:

Breast MRI Spectroscopy


Official Title:

Breast MRI Spectroscopy


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan Kettering Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sandra Brennan, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center

Study Dates

Start Date:May 2003
Completion Date:June 2016
Completion Type:Actual
Primary Completion Date:June 2016
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 28, 2016
First Received Date:December 18, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To determine if the data obtained can be reliably analyzed and useful to the final interpretation of the breast MRI examination.
Time Frame:12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment.
Time Frame:12 months
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Radiology/MRI scan
Description:MRI spectroscopy
Arm Name:Breast MR Spectroscopy

Study Arms

Study Arm Type:Experimental
Arm Name:Breast MR Spectroscopy
Description:Conventional images will be taken with standard pulse sequences. These images will be used for the diagnostic examination for which the patient will have been scheduled. Following the diagnostic study, a pulse sequence designed to obtain spectroscopy data will be used.This will be used on the existing magnets 1.5T and 3T. Memorial Sloan-Kettering Cancer Center has 1.5T and 3T magnets. The patient will have only one injection of contrast (gadolinium-DTPA) for the initial diagnostic study. No addi

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan Kettering Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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