Spectroscopy of Breast Tissue
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00918216|
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : July 16, 2014
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: fluorescence in situ hybridization Other: immunohistochemistry staining method Other: medical chart review Procedure: fluorescence spectroscopy Procedure: histopathologic examination Procedure: light-scattering spectroscopy|
- 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|
|Actual Enrollment :||141 participants|
|Official Title:||Spectroscopy of Breast Tissue|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Genetic: fluorescence in situ hybridization
- Ability of laser spectroscopy performed ex vivo to effectively distinguish between benign and malignant breast tumors [ Time Frame: At the time of biopsy ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918216
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Maryann Fitzmaurice, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|