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OpenTrials
Completed

NCT Number: NCT00582569

Breast MRI Spectroscopy, Department of Defense (DOD)

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.

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Key information

Conditions

Breast Lesion

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: conclusion of study

  2. To see if MRS can differentiate ben vs mal breast tissue with adequate specificity & sensitivity to be useful in clinical management.

    Time frame: conclusion of study

Secondary outcomes

  1. 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.

    Time frame: conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Dec 28, 2007
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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