Optical Coherence Tomography in Tissue Samples From Women Undergoing Mastectomy for the Treatment or Prevention of Breast Ductal Intraepithelial Neoplasia
NCT ID: NCT00807404
Last Updated: 2010-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2006-11-30
2009-03-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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DIAGNOSTIC
NONE
Interventions
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histopathologic examination
optical coherence tomography
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Principal Investigators
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I. B. Paz, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Countries
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Other Identifiers
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CHNMC-06008
Identifier Type: -
Identifier Source: secondary_id
CDR0000628769
Identifier Type: -
Identifier Source: org_study_id
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