Breast Cancer
Conditions
Keywords
Lumpectomy, Breast cancer, Optical coherence tomography, Tumor margin, Imaging
Brief summary
This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.
Interventions
DEVICEInterferometric Synthetic Aperture Microscopy
Optical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens.
Sponsors
Diagnostic Photonics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women 18 years of age or older 2. Signed informed consent form 3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery 4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure
Exclusion criteria
1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) 2. Neoadjuvant systemic therapy 3. All T4 tumors 4. Previous radiation in the operated breast 5. Prior surgical procedure in the same quadrant 6. Implants in the operated breast 7. Pregnancy 8. Lactation 9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients With All Positive/Close Margins Correctly Identified With the Device | 1 week after surgery |
| Number of Margins With False Positive Device Readings | 1 week after surgery |
Countries
United States
Outcome results
None listed