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Spectroscopy of Breast Tissue

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00918216
First received: June 10, 2009
Last updated: July 14, 2014
Last verified: July 2014

June 10, 2009
July 14, 2014
March 2008
October 2013   (final data collection date for primary outcome measure)
Ability of laser spectroscopy performed ex vivo to effectively distinguish between benign and malignant breast tumors [ Time Frame: At the time of biopsy ] [ Designated as safety issue: No ]
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.
Ability of laser spectroscopy performed ex vivo to effectively distinguish between benign and malignant breast tumors [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00918216 on ClinicalTrials.gov Archive Site
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Spectroscopy of Breast Tissue
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.

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).

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:

This study will involve up to 200 female patients already undergoing needle biopsy or surgical excision of a breast lesion identified clinically.

Non-Probability Sample

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.

Breast Cancer
  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00918216
CASE8107, P30CA043703, CASE8107, CASE-8107-CC441
No
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Maryann Fitzmaurice, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP