Laser Spectroscopy of Breast Tissue Through a Needle Device

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00918788
First received: June 10, 2009
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Laser Spectroscopy of Breast Tissue Through a Needle Device

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

This laboratory study is looking at samples of breast tissue from women who have undergone breast biopsy or surgery.


Enrollment: 17
Study Start Date: April 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: biologic sample preservation procedure
    Ex vivo samples of normal and malignant breast tissue; biopsy specimens are then fixed in formalin and submitted for histopathologic studies
    Other: immunohistochemistry staining method
    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.
    Other: light microscopy
    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).
    Other: medical chart review
    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.
    Procedure: histopathologic examination
    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.
    Procedure: needle biopsy
    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.
    Procedure: spectroscopy
    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.
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary Care Clinic

Criteria

DISEASE CHARACTERISTICS:

  • Discarded normal and malignant breast tissue surgical specimens from women who have undergone excisional breast biopsy, lumpectomy, mastectomy, or breast-reduction surgery at the University Hospitals-Case Medical Center
  • Hormone receptor status unknown

PATIENT CHARACTERISTICS:

  • Menopausal status unknown

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918788

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Maryann Fitzmaurice, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00918788     History of Changes
Other Study ID Numbers: CASE9107, P30CA043703, CASE9107, CASE-9107-CC482
Study First Received: June 10, 2009
Last Updated: August 20, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014