Quantitative Dynamic Contrast Enhanced Breast MRI

NCT00582764 | Completed

• 1 other identifier: 05-091
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Lesion; Lesion; Breast; Cancer; 05-091

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

Any patient undergoing MRI guided preoperative needle localization or MRI guided biopsy of the breast.

Other: perform dynamic contrast enhanced (DCE) MRI

Interventions

perform dynamic contrast enhanced (DCE) MRI OTHER

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.

1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• · scheduled for breast MRI interventional procedure for a known breast lesion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Oregon Health and Science University: collaborator
• DeltaPoint,Inc.: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center website

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

delta 24-sterol reductase; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sunitha Thakur, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: September 1, 2005
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

US (1)