Breast Cancer Clinical Trial

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

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.

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Full 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.

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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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

102

Study ID:

NCT00625417

Recruitment Status:

Completed

Sponsor:

Vanderbilt University

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There are 2 Locations for this study

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Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville Tennessee, 37064, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville Tennessee, 37064, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

102

Study ID:

NCT00625417

Recruitment Status:

Completed

Sponsor:


Vanderbilt University

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