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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00807404
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : May 27, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
City of Hope Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Precancerous Condition Procedure: histopathologic examination Procedure: optical coherence tomography Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Forward Image Guided Ductoscopy for Early Cancer Screening
Study Start Date : November 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Design of a portable forward imaging optical coherence tomography (OCT) needle probe
  2. Comparison of OCT imaging of ex-vivo breast tumor tissue sections with histology
  3. Development of an OCT needle probe that is capable of acquiring core biopsy samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807404


Locations
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United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: I. B. Paz, MD City of Hope Comprehensive Cancer Center
More Information
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ClinicalTrials.gov Identifier: NCT00807404    
Other Study ID Numbers: CDR0000628769
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-06008
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: May 2010
Keywords provided by City of Hope Medical Center:
ductal intraepithelial neoplasia
Additional relevant MeSH terms:
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Precancerous Conditions
Neoplasms