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Breast MRI Spectroscopy, Department of Defense (DOD)


N/A
18 Years
N/A
Not Enrolling
Female
Breast Lesion

Thank you

Trial Information

Breast MRI Spectroscopy, Department of Defense (DOD)


Our aim is to perform MR Spectroscopy (MRS) on 150 patients at the end of their clinically
indicated routine breast MRI guided biopsy and breast MRI guided needle localization
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. The MR Spectroscopy (MRS) will be administered
at Memorial Sloan Kettering Cancer Center, 1275 York Ave, NY,NY 10021.


Inclusion Criteria:



- Patient needs to be ≥ or = to 18 years of age

- scheduled for diagnostic breast MRI examination or interventional procedure for a
suspected or known breast lesion ≥ or = to 1 centimeter

Exclusion Criteria:

- Patients who would be normally excluded from undergoing an MRI examination include:

- Patients with a pacemaker, aneurysm clip or any other condition that would warrant
avoidance of a strong magnetic field

- Patients who are pregnant are excluded from participation of this study

- Patients who are unable to comply or complete the MRI exam due to claustrophobia or
high levels of anxiety.

- Patients undergoing chemotherapy

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

to determine if spectroscopy of the breast can be performed and can be functional in a clinical environment for breast lesions _> 1centimeter

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Sandra Brennan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

05-101

NCT ID:

NCT00582569

Start Date:

February 2006

Completion Date:

May 2013

Related Keywords:

  • Breast Lesion
  • Breast lesion
  • Spectroscopy
  • MRI

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021