MRI Evaluation of the Breast Areolar Margin and Paryenchyma

Breast Cancer Clinical Trial

— Breast MRI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01300585
• Other study ID #: Breast MRI
• Status: Terminated
• Phase: N/A
• First received: February 17, 2011
• Last updated: May 2, 2014
• Start date: February 2011
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Piedmont Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Piedmont Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Piedmont Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patterns of Breast Gland Attachment	Identify the various patterns of breast gland attachment to the overlying skin.	6 months	No