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Breast MRI Spectroscopy

Primary Purpose

Suspicion of, or Known Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Radiology/MRI scan

About this trial

This is an interventional diagnostic trial for Suspicion of, or Known Breast Cancer focused on measuring Breast cancer, MRI spectroscopy, Diagnostic radiology

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breast MR Spectroscopy

Arm 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 additional contrast will be administered. The additional sequence should take about 10 minutes, depending on breast size.

Outcomes

Primary Outcome Measures

To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment.

Secondary Outcome Measures

To determine if the data obtained can be reliably analyzed and useful to the final interpretation of the breast MRI examination.

Full Information

NCT ID

NCT00577915

First Posted

December 18, 2007

Last Updated

November 28, 2016

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00577915

Brief Title

Breast MRI Spectroscopy

Official Title

Breast MRI Spectroscopy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suspicion of, or Known Breast Cancer

Keywords

Breast cancer, MRI spectroscopy, Diagnostic radiology

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Breast MR Spectroscopy

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Radiology/MRI scan

Intervention Description

MRI spectroscopy

Primary Outcome Measure Information:

Title

To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandra Brennan, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

Breast MRI Spectroscopy

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