MRI Evaluation of the Breast Areolar Margin and Paryenchyma

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Other: MRI

• Registration Number: NCT01300585
• Lead Sponsor: Piedmont Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-21
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-02
• Last Update Posted: 2014-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI	MRI	All patients on study will undergo an MRI of the breast(s).

Primary Outcome Measures

Name	Time	Method
Patterns of Breast Gland Attachment	6 months	Identify the various patterns of breast gland attachment to the overlying skin.

Trial Locations

Locations (1)

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States