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

Primary Purpose

Precancerous Condition

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

histopathologic examination

optical coherence tomography

About this trial

This is an interventional diagnostic trial for Precancerous Condition focused on measuring ductal intraepithelial neoplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

City of Hope Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00807404

First Posted

December 10, 2008

Last Updated

May 26, 2010

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00807404

Brief Title

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

Official Title

Forward Image Guided Ductoscopy for Early Cancer Screening

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Precancerous Condition

Keywords

ductal intraepithelial neoplasia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Masking

None (Open Label)

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

histopathologic examination

Intervention Type

Procedure

Intervention Name(s)

optical coherence tomography

Primary Outcome Measure Information:

Title

Design of a portable forward imaging optical coherence tomography (OCT) needle probe

Title

Comparison of OCT imaging of ex-vivo breast tumor tissue sections with histology

Title

Development of an OCT needle probe that is capable of acquiring core biopsy samples

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

I. B. Paz, MD

Organizational Affiliation

City of Hope Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope Comprehensive Cancer Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010-3000

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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