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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00807404
First received: December 10, 2008
Last updated: May 26, 2010
Last verified: May 2010
  Purpose

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 Intervention
Precancerous Condition
Procedure: histopathologic examination
Procedure: optical coherence tomography

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Forward Image Guided Ductoscopy for Early Cancer Screening

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Design of a portable forward imaging optical coherence tomography (OCT) needle probe [ Designated as safety issue: No ]
  • Comparison of OCT imaging of ex-vivo breast tumor tissue sections with histology [ Designated as safety issue: No ]
  • Development of an OCT needle probe that is capable of acquiring core biopsy samples [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807404

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: I. B. Paz, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00807404     History of Changes
Other Study ID Numbers: CDR0000628769, P30CA033572, CHNMC-06008
Study First Received: December 10, 2008
Last Updated: May 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
ductal intraepithelial neoplasia

Additional relevant MeSH terms:
Precancerous Conditions
Carcinoma in Situ
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 17, 2014