Optical Coherence Tomography in Tissue Samples From Women Undergoing Mastectomy for the Treatment or Prevention of Breast Ductal Intraepithelial Neoplasia
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.
Procedure: histopathologic examination
Procedure: optical coherence tomography
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Forward Image Guided Ductoscopy for Early Cancer Screening|
- Design of a portable forward imaging optical coherence tomography (OCT) needle probe [ Designated as safety issue: No ]
- Comparison of OCT imaging of ex-vivo breast tumor tissue sections with histology [ Designated as safety issue: No ]
- Development of an OCT needle probe that is capable of acquiring core biopsy samples [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807404
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||I. B. Paz, MD||City of Hope Comprehensive Cancer Center|