MRI Evaluation to Assess the Relationship Between the Areolar Margin and Underlying Breast Paryenchyma Attachments to the Dermis

Piedmont Healthcare1 site in 1 country68 target enrollmentFebruary 2011

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Piedmont Healthcare
Enrollment: 68
Locations: 1
Primary Endpoint: Patterns of Breast Gland Attachment
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

May 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Piedmont Healthcare

Responsible Party

Sponsor

Eligibility 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