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Optical Spectroscopy in Evaluating Tumor Margins in Patients Who Have Undergone Surgery for Breast Tumors

This study is currently recruiting participants.
Verified April 2017 by Anita Mahadevan-Jansen, Vanderbilt University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00625417
First Posted: February 28, 2008
Last Update Posted: April 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Anita Mahadevan-Jansen, Vanderbilt University
  Purpose

RATIONALE: Diagnostic procedures, such as optical spectroscopy, may help learn the extent of disease and allow doctors to plan better treatment.

PURPOSE: This phase I trial is studying optical spectroscopy to see how well it works in evaluating tumor margins in patients who have undergone surgery for breast cancer.


Condition Intervention
Breast Cancer Procedure: breast biopsy Procedure: histopathologic examination Procedure: light-scattering spectroscopy Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Optical spectroscopy is applied to evaluate tumor margins in consenting patients who undergo surgery for breast tumors
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Breast Tumor Detection Using Optical Spectroscopy

Resource links provided by NLM:


Further study details as provided by Anita Mahadevan-Jansen, Vanderbilt University:

Primary Outcome Measures:
  • Development of a non-invasive detection tool that evaluates breast tumor margins in real-time to guide tumor resection during partial mastectomy procedures [ Time Frame: 1 year ]
  • Efficacy of using optical spectroscopy in differentiating breast tumor or tumor margins from normal breast tissue [ Time Frame: 2 years ]

Estimated Enrollment: 180
Study Start Date: August 2006
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Optical spectroscopy on tumor margins
Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery
Procedure: breast biopsy Procedure: histopathologic examination Procedure: light-scattering spectroscopy Procedure: therapeutic conventional surgery

Detailed Description:

OBJECTIVES:

  • To develop a non-invasive detection tool that evaluates breast tumor margins in real-time to guide tumor resection during partial mastectomy procedures.
  • To conduct an ex vivo optical spectroscopic study in operating rooms on breast tissue samples obtained immediately following resection to assess the efficacy of using this tool in differentiating breast tumor or tumor margins from normal breast tissue.

OUTLINE: Breast tissue samples obtained immediately following resection are examined in the operating room using optical spectroscopy to evaluate the margin tissue. During spectroscopy, all lights, except for the surgical lights, are turned off and the lateral, superior, medial, inferior, deep, and anterior margins of the breast tissue sample are examined using a fiber-optic probe, a nitrogen laser, and a broad band white light source. Reflectance and fluorescence spectra are measured at each of these margins by a system operator. The measured margins are then immediately marked by sutures placed by the surgeon. Additional margins may be measured at the surgeon's and system operator's discretion. The breast tissue sample is then delivered to surgical pathology, where shave biopsies are performed at the suture-marked sites to provide a direct correlation between spectroscopy measurements and tissue pathology.

Data collected in this study, including spectral data, gross diagnosis of the patient's tumor, and histological identities of all specimens collected, will be kept in the research record for at least 6 years after the study is finished.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Scheduled to undergo lumpectomy, partial or radical mastectomy, or excisional biopsy for breast tumor at Vanderbilt University Hospital
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Male or female
  • Menopausal status not specified
  • Not pregnant

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

INCLUSION CRITERIA Only adult patients between the ages of 18-99 years with breast tumor undergoing lumpectomy, radical mastectomy or excisional biopsy procedure will be considered

EXCLUSION CRITERIA Pregnant women will be excluded from the participation.

  Contacts and Locations
Information from the National Library of Medicine

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): NCT00625417


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: Anita Mahadeven-Jansen    615-343-4787      
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: Anita Mahadeven-Jansen    615-343-4787      
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Study Chair: Anita Mahadevan-Jansen, MD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Anita Mahadevan-Jansen, Professor, Biomedical Engineering, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00625417     History of Changes
Other Study ID Numbers: CDR0000587230
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-BRE-0718 ( Other Grant/Funding Number: VICC )
VU-VICC-060554 ( Other Grant/Funding Number: VICC )
First Submitted: February 27, 2008
First Posted: February 28, 2008
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Anita Mahadevan-Jansen, Vanderbilt University:
male breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

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