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Breast Tumor Detection Using Optical Spectroscopy


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

Breast Tumor Detection Using Optical Spectroscopy


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Anita Mahadevan-Jansen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000587230

NCT ID:

NCT00625417

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064