Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
- Conditions
- Breast Cancer
- Interventions
- Device: High Resolution Microendoscope
- Registration Number
- NCT00734838
- Lead Sponsor
- Duke University
- Brief Summary
The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 213
- Patients having a needle biopsy of a breast mass
- none
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Core needle biopsy High Resolution Microendoscope Patients needing a needle biopsy of a breast mass Reduction mammoplasty High Resolution Microendoscope Any patients scheduled for a reduction mammoplasty who would like to participate in a study to better understand breast cancer
- Primary Outcome Measures
Name Time Method Optical signatures Day of procedure (less than 10 minutes) The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States