Spectroscopy of Breast Tissue

Breast Cancer Clinical Trial

Official title:

Spectroscopy of Breast Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918216
• Other study ID #: CASE8107
• Secondary ID: P30CA043703CASE8
• Status: Completed
• Phase: Phase 1
• First received: June 10, 2009
• Last updated: July 14, 2014
• Start date: March 2008
• Est. completion date: October 2013

Study information

• Verified date: July 2014
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.
• 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.
• histopathologic examination
Hematoxylin and eosin stained sections of the tissue samples are examined by light microscopy for histopathological analysis.
• light-scattering spectroscopy
The freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or Raman spectroscopy.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No