Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Intervention Model Description
Optical spectroscopy is applied to evaluate tumor margins in consenting patients who undergo surgery for breast tumors
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Optical spectroscopy on tumor margins
Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery
  • Procedure: breast biopsy
  • Procedure: histopathologic examination
  • Procedure: light-scattering spectroscopy
  • Procedure: therapeutic conventional surgery

Recruiting Locations

Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee 37064
Contact:
Anita Mahadeven-Jansen
615-343-4787

Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee 37064
Contact:
Anita Mahadeven-Jansen
615-343-4787

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232-6838
Contact:
Clinical Trials Office - Vanderbilt-Ingram Cancer Center
800-811-8480

More Details

NCT ID
NCT00625417
Status
Recruiting
Sponsor
Vanderbilt University

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.