Breast MRI: MRI Evaluation of the Breast Areolar Margin and Paryenchyma

Sponsor
Piedmont Healthcare (Other)
Overall Status
Terminated
CT.gov ID
NCT01300585
Collaborator
(none)
68
1
1
38.9
1.7

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: MRI
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Patterns of Breast Gland Attachment [6 months]

    Identify the various patterns of breast gland attachment to the overlying skin.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Piedmont Hospital Atlanta Georgia United States 30309

Sponsors and Collaborators

  • Piedmont Healthcare

Investigators

  • Principal Investigator: Heather Richardson, MD, Piedmont Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT01300585
Other Study ID Numbers:
  • Breast MRI
First Posted:
Feb 21, 2011
Last Update Posted:
May 5, 2014
Last Verified:
May 1, 2014
Keywords provided by Piedmont Healthcare

Study Results

No Results Posted as of May 5, 2014