Optical Spectroscopy in Evaluating Tumor Margins in Patients Who Have Undergone Surgery for Breast Tumors
- Conditions
- Breast Cancer
- Interventions
- Procedure: breast biopsyProcedure: histopathologic examinationProcedure: light-scattering spectroscopyProcedure: therapeutic conventional surgery
- Registration Number
- NCT00625417
- Lead Sponsor
- Vanderbilt University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Optical spectroscopy on tumor margins light-scattering spectroscopy Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery Optical spectroscopy on tumor margins histopathologic examination Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery Optical spectroscopy on tumor margins breast biopsy Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery Optical spectroscopy on tumor margins therapeutic conventional surgery Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery
- Primary Outcome Measures
Name Time Method Development of a non-invasive detection tool that evaluates breast tumor margins in real-time to guide tumor resection during partial mastectomy procedures 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Vanderbilt-Ingram Cancer Center at Franklin
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center - Cool Springs
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States