Optical Spectroscopy in Evaluating Tumor Margins in Patients Who Have Undergone Surgery for Breast Tumors
Breast Tumor Detection Using Optical Spectroscopy
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.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, United States, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Nashville, Tennessee, United States, 37064
- Vanderbilt-Ingram Cancer Center at Franklin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Optical spectroscopy on tumor margins
Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 year
|
|
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
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Anita Mahadevan-Jansen, MD, Vanderbilt-Ingram Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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