MRI Evaluation of the Breast Areolar Margin and Paryenchyma (Breast MRI)
The purpose of this study is to test a new method of defining patterns of how breast glands are or are not attached to the overlying skin. All patients will have markers placed on both breasts and will undergo an MRI. MRI results will be examined to identify the pattern of breast gland attachment to the overlying skin. This will help identify patients which may benefit from areolar sparing and/or nipple sparing technique and which patients should be treated by standard mastectomy.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||MRI Evaluation to Assess the Relationship Between the Areolar Margin and Underlying Breast Paryenchyma Attachments to the Dermis|
- Patterns of Breast Gland Attachment [ Time Frame: 6 months ] [ Designated as safety issue: No ]Identify the various patterns of breast gland attachment to the overlying skin.
|Study Start Date:||February 2011|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
All patients on study will undergo an MRI of the breast(s).
Patients who qualify for the study and consent to be included will undergo placement of areola and nipple markers that will be held in place with tape for the duration of the ordered MRI study. The markers consist of latex-free plastic tubing filled with vegetable based hydrogenated oil that is solid at room temperature. This creates a fat density marker that will define the areola but does not interfere with or create artifact onto the underlying tissue. The marker can be placed by the investigator or available MRI technician instructed in marker placement. The patient will then undergo the MRI. The patients participation in the study will end with the MRI.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300585
|United States, Georgia|
|Atlanta, Georgia, United States, 30309|
|Principal Investigator:||Heather Richardson, MD||Piedmont Hospital|