Optical Coherence Tomography in Tissue Samples From Women Undergoing Mastectomy for the Treatment or Prevention of Breast Ductal Intraepithelial Neoplasia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: New diagnostic procedures, such as optical coherence tomography, may be effective in finding tumor cells. PURPOSE: This clinical trial is studying optical coherence tomography in tissue samples from women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial neoplasia.

Detailed Description
-----------------
OBJECTIVES: To design and construct a portable forward imaging optical coherence tomography (OCT) needle probe. To compare OCT imaging of ex-vivo breast tumor tissue sections with histology to form the basis of an image library for in-vivo work. To initiate development of an OCT needle probe that is capable of acquiring core biopsy samples. OUTLINE: Breast tissue samples are obtained during mastectomy and analyzed ex-vivo by optical coherence tomography (OCT) and by histopathological examination. Once routine pathological evaluation and tissue sampling are completed, OCT imaging is performed using a portable forward imaging needle probe that is inserted through the ducts of the tissue sample. OCT images of the surface of the closest margin to the tumor (if present) as well as images of the duct(s) in the nipple areola complex (after dilation) are obtained. Images of a cross section of the tumor (after the sample has been sliced by the pathologist) are also obtained. The OCT images are then correlated with tissue histology. The images are used to create a correlation histology-OCT atlas for the evaluation of subsequent images and for future reference.

Official Title
-----------------
Forward Image Guided Ductoscopy for Early Cancer Screening

Conditions
-----------------
Precancerous Condition

Intervention / Treatment
-----------------
* Procedure: histopathologic examination
* Procedure: optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Undergoing mastectomy at the City of Hope Breast Center for the treatment or prevention of breast ductal intraepithelial neoplasia PATIENT CHARACTERISTICS: Fertile and/or pregnant patients allowed PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: histopathologic examination|nan|
|Procedure: optical coherence tomography|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Design of a portable forward imaging optical coherence tomography (OCT) needle probe |  |  | 
| Comparison of OCT imaging of ex-vivo breast tumor tissue sections with histology |  |  | 
| Development of an OCT needle probe that is capable of acquiring core biopsy samples |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ductal intraepithelial neoplasia