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Breast MRI Spectroscopy, Department of Defense (DOD)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582569
First received: December 21, 2007
Last updated: May 9, 2013
Last verified: May 2013

December 21, 2007
May 9, 2013
February 2006
May 2013   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00582569 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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Breast MRI Spectroscopy, Department of Defense (DOD)
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Include women with lesions, > or = to 1 centimeter that will undergo a diagnostic MRI exam, an MRI guided biopsy, or an MRI guided needle localization, such as women with breast cancer or women with clinical and/or mammographic findings suspicious for breast masses. However, any known breast lesion, benign or malignant, will be appropriate for evaluation with MR spectroscopy.

Breast Lesion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582569
05-101
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Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Department of Defense
Principal Investigator: Sandra Brennan, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP