Laser Spectroscopy of Breast Tissue Through a Needle Device
|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: NCT00918788|
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : August 22, 2013
RATIONALE: Collecting and storing samples of breast tissue from patients who have undergone biopsy or surgery to test in the laboratory may help the study of cancer in the future.
PURPOSE: This laboratory study is looking at samples of breast tissue from women who have undergone breast biopsy or surgery.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: biologic sample preservation procedure Other: immunohistochemistry staining method Other: light microscopy Other: medical chart review Procedure: histopathologic examination Procedure: needle biopsy Procedure: spectroscopy|
- 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 After the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is marked at the site of the spectral measurements.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.
|Study Type :||Observational|
|Actual Enrollment :||17 participants|
|Official Title:||Laser Spectroscopy of Breast Tissue Through a Needle Device|
|Study Start Date :||April 2008|
|Primary Completion Date :||February 2013|
|Study Completion Date :||February 2013|
Other: biologic sample preservation procedure
- Collection of optical spectra from normal and malignant breast tissue samples [ Time Frame: at time of excisional breast biopsy, lumpectomy, mastectomy or breast reduction surgery ]
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): NCT00918788
|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|