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

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ClinicalTrials.gov Identifier: NCT00625417
Recruitment Status : Recruiting
First Posted : February 28, 2008
Last Update Posted : May 28, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Anita Mahadevan-Jansen, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE February 27, 2008
First Posted Date  ICMJE February 28, 2008
Last Update Posted Date May 28, 2019
Study Start Date  ICMJE August 2006
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • 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 ]
    A 3-D scanner that can scan a breast lump will be developed so that breast margin may be evaluated with Raman spectroscopy
  • Evaluated optical spectroscopy in differentiating breast tumor or tumor margins from normal breast tissue [ Time Frame: 2 years ]
    This device will be tested in patient specimens intra-operatively before going to pathology and compared to histopathology to evaluate the ability of the device to detect margin up to 2 mm deep
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
  • Development of a non-invasive detection tool that evaluates breast tumor margins in real-time to guide tumor resection during partial mastectomy procedures
  • Efficacy of using optical spectroscopy in differentiating breast tumor or tumor margins from normal breast tissue
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optical Spectroscopy in Evaluating Tumor Margins in Patients Who Have Undergone Surgery for Breast Tumors
Official Title  ICMJE Breast Tumor Detection Using Optical Spectroscopy
Brief Summary

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Procedure: breast biopsy
  • Procedure: histopathologic examination
  • Procedure: light-scattering spectroscopy
  • Procedure: therapeutic conventional surgery
Study Arms  ICMJE Experimental: Optical spectroscopy on tumor margins
Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery
Interventions:
  • Procedure: breast biopsy
  • Procedure: histopathologic examination
  • Procedure: light-scattering spectroscopy
  • Procedure: therapeutic conventional surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2017)
180
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625417
Other Study ID Numbers  ICMJE CDR0000587230
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-BRE-0718 ( Other Grant/Funding Number: VICC )
VU-VICC-060554 ( Other Grant/Funding Number: VICC )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This is still an early phase study and the data is not ready for dissemination yet.
Responsible Party Anita Mahadevan-Jansen, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Anita Mahadevan-Jansen, MD Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP