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OpenTrials
Completed

NCT Number: NCT00577915

Breast MRI Spectroscopy

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.

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Key information

Conditions

Suspicion of, or Known Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Radiology/MRI scan

Other

MRI spectroscopy

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2003
Primary completion
2016
Study completion
2016
First posted
Dec 20, 2007
Registry last updated
Nov 29, 2016

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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