Breast MRI Spectroscopy, Department of Defense (DOD)

Breast Lesion Clinical Trial

Official title:

Breast MRI Spectroscopy, Department of Defense (DOD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582569
• Other study ID #: 05-101
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: May 9, 2013
• Start date: February 2006
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this new imaging method is to provide physicians with additional information not available with standard imaging methods. This includes information about the make up of different breast diseases. Using spectroscopy data, it may be possible to tell the difference between benign conditions of the breast from malignant tumors and provide more accurate information than can be obtained with regular MRI. Along with the MRI a new method of evaluating 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 look different than the regular MRI pictures. Performing spectroscopy on a 1.5T magnet adds another imaging sequence (another scan) to the routine MRI protocol, thus increasing exam time (extra 10-15 minutes). This study will enroll patients who are scheduled for a Magnetic Resonance Imaging (MRI) examination ordered by their primary physician.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Lesion

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to determine if spectroscopy of the breast can be performed and can be functional in a clinical environment for breast lesions _> 1centimeter		conclusion of study	No
Primary	To see if MRS can differentiate ben vs mal breast tissue with adequate specificity & sensitivity to be useful in clinical management.		conclusion of study	No
Secondary	if the data obtained can differentiate among various histologic subtypes of invasive and non-invasive breast cancers, and can be reliably analyzed and be useful to the final interpretation of the breast MRI examination.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center website