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

Forward Image Guided Ductoscopy for Early Cancer Screening

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00807404

Enrollment

Registered

2008-12-11

Start date

2006-11-30

Completion date

2009-03-31

Last updated

2010-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Precancerous Condition

Keywords

ductal intraepithelial neoplasia

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.

Interventions

PROCEDUREhistopathologic examination

PROCEDUREoptical coherence tomography

Study design

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * 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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026