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.
Looking for future studies?
Notify MeKey information
Conditions
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
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
histopathologic examination
Procedurelight-scattering spectroscopy
Proceduretherapeutic conventional surgery
ProcedurePrimary outcomes
-
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
-
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.
View the official ClinicalTrials.gov record (opens in a new tab)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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer
NCT03387553
Breast Cancer, Breast Cancer Female
Tampa, Florida, United States
View Trial DetailsEORTC Quality of Life Measurement in Males With Breast Cancer
NCT07455110
Breast Cancer, Breast Diseases
Wuppertal, North Rhine-Westphalia, Germany
View Trial DetailsMolecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer
NCT00897702
Breast Cancer, Breast Diseases
Basking Ridge, New Jersey, United States
View Trial DetailsLapatinib and Tamoxifen in Treating Patients With Advanced or Metastatic Breast Cancer
NCT00424164
Breast Cancer, Breast Diseases
Dijon, France
View Trial Details