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

City of Hope

Status: Completed

Conditions: Precancerous Condition

Treatments: Procedure: optical coherence tomography; Procedure: histopathologic examination

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00807404

CDR0000628769

P30CA033572 (U.S. NIH Grant/Contract)

CHNMC-06008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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