Optical Coherence Tomography in Tissue Samples From Women Undergoing Mastectomy for the Treatment or Prevention of Breast Ductal Intraepithelial Neoplasia
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|ClinicalTrials.gov Identifier: NCT00807404|
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : May 27, 2010
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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.
|Condition or disease||Intervention/treatment||Phase|
|Precancerous Condition||Procedure: histopathologic examination Procedure: optical coherence tomography||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Masking:||None (Open Label)|
|Official Title:||Forward Image Guided Ductoscopy for Early Cancer Screening|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Undergoing mastectomy at the City of Hope Breast Center for the treatment or prevention of breast ductal intraepithelial neoplasia
- Fertile and/or pregnant patients allowed
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Other Study ID Numbers:||
P30CA033572 ( U.S. NIH Grant/Contract )
|First Posted:||December 11, 2008 Key Record Dates|
|Last Update Posted:||May 27, 2010|
|Last Verified:||May 2010|
ductal intraepithelial neoplasia