Laser Spectroscopy of Breast Tissue Through a Needle Device

August 20, 2013 updated by: Case Comprehensive Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 After the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is marked at the site of the spectral measurements.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.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Primary Care Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at time of excisional breast biopsy, lumpectomy, mastectomy or breast reduction surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Maryann Fitzmaurice, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 10, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 22, 2013

Last Update Submitted That Met QC Criteria

August 20, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE9107 (Other Identifier: Case Comprehensive Cancer Center)
  • P30CA043703 (U.S. NIH Grant/Contract)
  • CASE-9107-CC482 (Other Identifier: Case Cancer IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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