Optical Coherence Tomography in Tissue Samples From Women Undergoing Mastectomy for the Treatment or Prevention of Breast Ductal Intraepithelial Neoplasia

Not Applicable

Completed

• Conditions: Precancerous Condition

• Registration Number: NCT00807404
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-26
• Last Update Posted: 2010-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States