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OpenTrials
Completed

NCT Number: NCT00625417

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

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

breast biopsy

Procedure

histopathologic examination

Procedure

light-scattering spectroscopy

Procedure

therapeutic conventional surgery

Procedure

Primary outcomes

  1. Development of a non-invasive detection tool that evaluates breast tumor margins in real-time to guide tumor resection during partial mastectomy procedures

    Time frame: 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

  2. Evaluated optical spectroscopy in differentiating breast tumor or tumor margins from normal breast tissue

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Breast Tumor Detection Using Optical Spectroscopy

Important dates

Study start
2006
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2008
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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