Optical Spectroscopy in Evaluating Tumor Margins in Patients Who Have Undergone Surgery for Breast Tumors
Breast Cancer
Conditions: 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
Study Type
Study Phase
Phase 1
Study Design
Masking: Open Label, Primary Purpose: Diagnostic
Name: breast biopsy Type: Procedure
Name: histopathologic examination Type: Procedure
Name: light-scattering spectroscopy Type: Procedure
Name: therapeutic conventional surgery Type: Procedure
Overall Status
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

- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both

- Scheduled to undergo lumpectomy, partial or radical mastectomy, or excisional biopsy for breast tumor at Vanderbilt University Hospital

- Hormone receptor status not specified


- Male or female

- Menopausal status not specified

- Not pregnant


- See Disease Characteristics
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center - 800-811-8480
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Status: Recruiting
Contact: Anita Mahadeven-Jansen - 615-343-4787
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Status: Recruiting
Contact: Anita Mahadeven-Jansen - 615-343-4787
Start Date
August 2006
Vanderbilt University
Vanderbilt University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page