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

December 10, 2008
May 26, 2010
November 2006
March 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00807404 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
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Masking: Open Label
Primary Purpose: Diagnostic
Precancerous Condition
  • Procedure: histopathologic examination
  • Procedure: optical coherence tomography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00807404
CDR0000628769, P30CA033572, CHNMC-06008
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City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: I. B. Paz, MD Beckman Research Institute
City of Hope Medical Center
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP