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Laser Spectroscopy of Breast Tissue Through a Needle Device


N/A
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Laser Spectroscopy of Breast Tissue Through a Needle Device


OBJECTIVES:

- To prove that optical spectra collected by inserting an optical fiber probe into breast
tissue through a biopsy needle can be of adequate quality to render a spectroscopic
diagnosis.

OUTLINE: Optical spectra are acquired from ex vivo samples of normal and malignant breast
tissue using diffuse reflectance, fluorescence, and Raman spectroscopy. Tissue spectra are
measured using a portable clinical spectroscopy device with front- and side-viewing optical
fiber probes that are inserted into the breast tissue through a hollow biopsy needle. After
the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is
marked at the site of the spectral measurements. The biopsy specimens are then fixed in
formalin and submitted for histopathologic studies using standard light microscopy
techniques (i.e., H&E staining and IHC). Additional histochemical, immunohistochemical, and
fluorescent in situ stains may be performed to support the diagnosis or to better understand
the spectroscopy results.

Medical records are reviewed to obtain information from the pathology report on patient
demographics, pathological characteristics of the surgical specimen, and clinical indication
for the surgical procedure.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Discarded normal and malignant breast tissue surgical specimens from women who have
undergone excisional breast biopsy, lumpectomy, mastectomy, or breast-reduction
surgery at the University Hospitals-Case Medical Center

- Hormone receptor status unknown

PATIENT CHARACTERISTICS:

- Menopausal status unknown

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Collection of optical spectra from normal and malignant breast tissue samples

Outcome Time Frame:

at time of excisional breast biopsy, lumpectomy, mastectomy or breast reduction surgery

Safety Issue:

No

Principal Investigator

Maryann Fitzmaurice, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE9107

NCT ID:

NCT00918788

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065