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Forward Image Guided Ductoscopy for Early Cancer Screening


N/A
18 Years
N/A
Not Enrolling
Female
Precancerous Condition

Thank you

Trial Information

Forward Image Guided Ductoscopy for Early Cancer Screening


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

I. B. Paz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000628769

NCT ID:

NCT00807404

Start Date:

November 2006

Completion Date:

March 2009

Related Keywords:

  • Precancerous Condition
  • ductal intraepithelial neoplasia
  • Precancerous Conditions
  • Carcinoma in Situ

Name

Location

City of Hope Comprehensive Cancer Center Duarte, California  91010