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Spectroscopy of Breast Tissue


Phase 1
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Spectroscopy of Breast Tissue


OBJECTIVES:

Primary

- To determine whether laser spectroscopy of breast tissue performed ex vivo can
effectively distinguish between benign and malignant breast tumors in women undergoing
needle biopsy or surgical excision of a breast lesion identified clinically.

OUTLINE: Patients undergo tissue sample collection via needle biopsy or surgical excision of
a breast lesion. A radiogram of the sample may be obtained to identify target areas for
spectroscopic evaluation. The freshly excised breast tissue samples are analyzed ex vivo by
fluorescence, reflectance, and/or Raman spectroscopy. After completion of the spectroscopic
examination, the tissue samples are submitted for diagnostic pathologic evaluation.
Hematoxylin and eosin stained sections of the tissue samples are examined by light
microscopy for histopathological analysis. The results of the pathological examination are
then compared with the spectroscopic findings and radiological findings (if the biopsy was
performed for a suspect lesion on mammography) to determine if any correlation can be
established and which spectroscopic technique provides the most useful diagnostic
information. Additional histochemical, immunohistochemical, and fluorescence in situ stains
may be performed to support the diagnosis or to better understand the spectroscopy results.

Patients' medical charts are reviewed to obtain clinical information (e.g., age, sex, and
race; results of pathology reports and reports of ancillary studies, including estrogen
receptor, progesterone receptor, and HER-2 receptor testing, for the surgical specimen being
studied and for any other related surgical specimens; menstrual status and date of last
menstrual period; clinical history of breast mass or abnormal mammogram and related
mammography report; clinical history of hormone replacement therapy, birth control pills, or
oophorectomy; and clinical history of chemotherapy or other adjuvant therapy for breast
cancer).

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Clinically identified breast lesion

- Planning to undergo needle biopsy or surgical excision of the breast lesion

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

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

Outcome Measure:

Ability of laser spectroscopy performed ex vivo to effectively distinguish between benign and malignant breast tumors

Outcome Description:

The data will be taken with a portable spectroscopy system that can perform fluorescence, reflectance and Raman spectroscopy simultaneously through a single fiber optic probe.

Outcome Time Frame:

At the time of biopsy

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: Federal Government

Study ID:

CASE8107

NCT ID:

NCT00918216

Start Date:

March 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