Quantitative Dynamic Contrast Enhanced Breast MRI

Breast Cancer Clinical Trial

Official title:

Quantitative Dynamic Contrast Enhanced Breast MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582764
• Other study ID #: 05-091
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: July 7, 2015
• Start date: September 2005
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	DeltaPoint,Inc., Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess whether the new quantitative MRI method can discriminate between malignant and nonmalignant breast lesions among the lesions seen in conventional MRI.		December 2008	No

External Links

•   Memorial Sloan Kettering Cancer Center website