Spectroscopy of Breast Tissue

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Spectroscopy of Breast Tissue

Conditions
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Breast Cancer

Intervention / Treatment
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* Genetic: fluorescence in situ hybridization
* Other: immunohistochemistry staining method
* Other: medical chart review
* Procedure: fluorescence spectroscopy
* Procedure: histopathologic examination
* Procedure: light-scattering spectroscopy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: fluorescence in situ hybridization|Additional histochemical, immunohistochemical, and fluorescence in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.|
|Other: immunohistochemistry staining method|Additional histochemical, immunohistochemical, and fluorescence in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.|
|Other: medical chart review|Patients' medical charts are reviewed to obtain clinical information|
|Procedure: fluorescence spectroscopy|The freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or Raman spectroscopy.|
|Procedure: histopathologic examination|Hematoxylin and eosin stained sections of the tissue samples are examined by light microscopy for histopathological analysis.|
|Procedure: light-scattering spectroscopy|The freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or Raman spectroscopy.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer