MRI Evaluation of the Breast Areolar Margin and Paryenchyma (Breast MRI)
This study is currently recruiting participants.
Verified October 2013 by Piedmont Healthcare
Information provided by (Responsible Party):
First received: February 17, 2011
Last updated: October 19, 2013
Last verified: October 2013
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||MRI Evaluation to Assess the Relationship Between the Areolar Margin and Underlying Breast Paryenchyma Attachments to the Dermis
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Have one of the following indications for MRI study of the breast - screening for high risk without evidence of disease, have existing breast cancer with need for evaluation of extent of disease or to rule out additional occult cancer, or to have an equivocal mammogram or ultrasound requiring additional information from MRI.
- No prior breast surgery including prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants.
- Capable of fitting into the MRI machine.
- Permission to contact and consent the patient to participate from the investigator(s)
- Provide written informed consent and Authorization for Use/Disclosure of PHI
- Have a contraindication to MRI study.
- Prior breast surgery - this includes: prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants [Patients may have undergone prior percutaneous (needle) biopsy or fine needle aspiration]
- Inability to fit into the MRI machine.
- Psychological factors that may interfere with successful completion of the study
- Refusal to provide written informed consent and/or Authorization for Use/Disclosure of PHI
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300585
|Atlanta, Georgia, United States, 30309 |
|Contact: Heather Richardson, MD 404-351-1002 email@example.com |
|Principal Investigator: Heather Richardson, MD |
||Heather Richardson, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 17, 2011
||October 19, 2013
||United States: Institutional Review Board
Keywords provided by Piedmont Healthcare:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2013
Neoplasms by Site