Spectroscopy of Breast Tissue

RATIONALE: Diagnostic procedures, such as laser spectroscopy, may help find and diagnose breast cancer.

PURPOSE: This phase I trial is studying laser spectroscopy to see how well it works in diagnosing breast cancer in women with breast lesions.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Genetic: fluorescence in situ hybridization; Other: immunohistochemistry staining method; Other: medical chart review; Procedure: fluorescence spectroscopy; Procedure: histopathologic examination; Procedure: light-scattering spectroscopy

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This study will involve up to 200 female patients already undergoing needle biopsy or surgical excision of a breast lesion identified clinically. The patients will be recruited from the General Surgery and Radiology practices of the co-investigators.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of laser spectroscopy performed ex vivo to effectively distinguish between benign and malignant breast tumors	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.	At the time of biopsy

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Maryann Fitzmaurice, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CASE8107 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); CASE-8107-CC441 (Other Identifier: Cancer Center IRB)