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MRI Evaluation of the Breast Areolar Margin and Paryenchyma (Breast MRI)

This study is currently recruiting participants.
Verified December 2012 by Piedmont Healthcare
Sponsor:
Information provided by (Responsible Party):
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT01300585
First received: February 17, 2011
Last updated: December 16, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Other: MRI

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MRI
All patients on study will undergo an MRI of the breast(s).
 Other: MRI
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300585

Contacts
Contact: Heather Richardson, MD 404-351-1002 kippahrh@hotmail.com

Locations
United States, Georgia
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Heather Richardson, MD     404-351-1002     kippahrh@hotmail.com    
Principal Investigator: Heather Richardson, MD            
Sponsors and Collaborators
Piedmont Healthcare
Investigators
Principal Investigator: Heather Richardson, MD Piedmont Hospital
  More Information

No publications provided

Responsible Party: Piedmont Healthcare
ClinicalTrials.gov Identifier: NCT01300585     History of Changes
Other Study ID Numbers: Breast MRI
Study First Received: February 17, 2011
Last Updated: December 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Piedmont Healthcare:
Breast
Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013