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Clinical Trials/NCT00807404
NCT00807404
Completed
Not Applicable

Forward Image Guided Ductoscopy for Early Cancer Screening

City of Hope Medical Center1 site in 1 country50 target enrollmentNovember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Precancerous Condition
Sponsor
City of Hope Medical Center
Enrollment
50
Locations
1
Primary Endpoint
Design of a portable forward imaging optical coherence tomography (OCT) needle probe
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
March 2009
Last Updated
15 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
City of Hope Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (1)

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