Breast MRI Spectroscopy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00577915

Enrollment

150

Registered

2007-12-20

Start date

2003-05-31

Completion date

2016-06-30

Last updated

2016-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspicion of, or Known Breast Cancer

Keywords

Breast cancer, MRI spectroscopy, Diagnostic radiology

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.

Interventions

OTHERRadiology/MRI scan

MRI spectroscopy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment.	12 months

Secondary

Measure	Time frame
To determine if the data obtained can be reliably analyzed and useful to the final interpretation of the breast MRI examination.	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026