Clinical Trials /

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

NCT00625417

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Optical Spectroscopy in Evaluating Tumor Margins in Patients Who Have Undergone Surgery for Breast Tumors
  • Official Title: Breast Tumor Detection Using Optical Spectroscopy

Clinical Trial IDs

  • ORG STUDY ID: CDR0000587230
  • SECONDARY ID: P30CA068485
  • SECONDARY ID: VU-VICC-BRE-0718
  • SECONDARY ID: VU-VICC-060554
  • NCT ID: NCT00625417

Conditions

  • Breast Cancer

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Optical spectroscopy on tumor marginsExperimentalOptical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery

    Eligibility 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.
          
    Maximum Eligible Age:99 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure: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
    Safety Issue:
    Description:

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Vanderbilt University

    Trial Keywords

    • 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

    Last Updated

    April 13, 2017