MRI Evaluation of the Breast Areolar Margin and Paryenchyma

Stopped early · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01300585

Run by

Piedmont Healthcare

People needed

68

Starts

2011-02-01

Expected to finish

2014-05-01

Last updated by the study team

2014-05-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Piedmont Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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