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.
Recruiting
N/A
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Optical spectroscopy on tumor margins | Experimental | Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery |
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.
| Maximum Eligible Age: | 99 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | 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 |
| Safety Issue: | |
| Description: | A 3-D scanner that can scan a breast lump will be developed so that breast margin may be evaluated with Raman spectroscopy |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Vanderbilt University |
May 28, 2020
