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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2021-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Optical spectroscopy is applied to evaluate tumor margins in consenting patients who undergo surgery for breast tumors

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Optical spectroscopy on tumor margins

Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery

Group Type EXPERIMENTAL

breast biopsy

Intervention Type PROCEDURE

histopathologic examination

Intervention Type PROCEDURE

light-scattering spectroscopy

Intervention Type PROCEDURE

therapeutic conventional surgery

Intervention Type PROCEDURE

Interventions

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breast biopsy

Intervention Type PROCEDURE

histopathologic examination

Intervention Type PROCEDURE

light-scattering spectroscopy

Intervention Type PROCEDURE

therapeutic conventional surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No