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Quantitative Dynamic Contrast Enhanced Breast MRI

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Oregon Health and Science University
DeltaPoint,Inc.
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582764
First received: December 21, 2007
Last updated: July 12, 2012
Last verified: July 2012
History of Changes

December 21, 2007
July 12, 2012
September 2005
September 2013   (final data collection date for primary outcome measure)
To assess whether the new quantitative MRI method can discriminate between malignant and nonmalignant breast lesions among the lesions seen in conventional MRI. [ Time Frame: December 2008 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00582764 on ClinicalTrials.gov Archive Site
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Quantitative Dynamic Contrast Enhanced Breast MRI
Quantitative Dynamic Contrast Enhanced Breast MRI

The purpose of this study is to see if dynamic contrast enhanced (DCE) MRI imaging makes it possible to distinguish benign conditions of the breast from malignant tumors and provide better information than can be obtained with regular MRI. DCE MRI uses a new way of collecting and analyzing the images or pictures which provides doctors extra information not available with standard imaging methods. This includes information about the blood vessels of different breast diseases. Pictures produced this way look just like the regular MRI pictures. The DCE MRI adds another imaging sequence (another scan) to the MRI examination ordered by your physician to evaluate your breast lesion, thus increasing the exam time (extra 10 min). The information gained from doing the new test, the DCE MRI, will not be used in your treatment and will not affect the type of care you receive for your breast lesions.

Our aim is to perform dynamic contrast enhanced (DCE) MRI on 150 patients during their routine breast MRI examination at MSKCC. This will add extra 10 min scanning time to the routine examination. High resolution (submillimeter) parametric maps of pathophysiologic quantities, such as tumor vessel permeability, tumor perfusion, extracellular extravascular volume fraction, will be generated from the DCE MRI data. These results will be correlated with pathology to determine new pharmacokinetic threshold so that the negative predictive value for benign lesions is close to 100%. The improvement in diagnostic specificity may help to reduce unnecessary biopsies in the future.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Participants will be selected at the time of the MRI interventional procedure by the radiologist who is protocoling the MRI examinations and who is an investigator on this protocol. Any known breast lesion, benign or malignant, will be appropriate for evaluation with DCE MRI. Pathology results will be obtained for each patient as a result of surgery or MRI guided biopsy, allowing correlation between the pathology and DCE MRI data.
Breast Cancer
Other: perform dynamic contrast enhanced (DCE) MRI
With an IV catheter in place, the patient will lie prone on the MRI scanner table with the breasts positioned in the commercial breast coil and then be moved feet first to the center of the MRI scanner. The only difference introduced by the addition of DCE MRI is that before the patient is moved into the scanner for the first time, the IV catheter will be hooked up with a programmable power injector (Medrad, Indianola, PA) which is loaded with Gd contrast and saline. The contrast injection and saline flush will be delivered by the injector while the patient is inside the scanner and the DCE MRI data collection is in process. The Gd contrast dose used for DCE MRI is the same as for clinical MRI: 0.1 mmol/kg. The injection speed of 2 mL/sec is safe and similar to that of manual injection.
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Any patient undergoing MRI guided preoperative needle localization or MRI guided biopsy of the breast.
Intervention: Other: perform dynamic contrast enhanced (DCE) MRI
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

· scheduled for breast MRI interventional procedure for a known 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.
  • patients who are unable to cooperate for an MRI, and/or have known reaction to gadolinium contrast agent.
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582764
05-091
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Oregon Health and Science University
  • DeltaPoint,Inc.
Principal Investigator: Jason Koutcher, MD,PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
July 2012

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