Precancerous Condition Clinical Trial
Official title:
Forward Image Guided Ductoscopy for Early Cancer Screening
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.
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.
;
Masking: Open Label, Primary Purpose: Diagnostic
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