Breast Cancer
Conditions
Brief summary
This is a single-arm, prospective, study of an optical imaging device on approximately twenty (20) subjects undergoing lumpectomies at one study site. In vivo and ex vivo imaging will be performed on study subjects with results being compared to final pathology.
Detailed description
This study is a single-center, prospective, two-part open label study of an optical imaging device on approximately twenty (20) subjects at one (1) study site. Patients scheduled to undergo a lumpectomy will be recruited by the clinical investigators at the investigational site in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the in vivo and ex vivo breast tissue samples using the study device during their lumpectomy. All specimens will be marked with India ink and undergo standard post-operative histology, and digital histology images corresponding to the inked locations will be obtained. The images and the matched digitized post-operative histology images will then be randomized and read by a blinded, independent pathologist. Sensitivity and specificity will be calculated.
Interventions
DEVICEOptical Coherence Tomography
Optical coherence tomography will be used to image tissue structure on excised and in vivo specimens.
Sponsors
University of Illinois at Chicago
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 ICF 3. Women who have been histologically diagnosed with invasive ductal carcinoma or invasive lobular carcinoma of the breast prior to surgery 4. Planning breast preservation 5. Patients 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 |
|---|---|
| The sensitivity and specificity of Optical Coherence Tomography to identify whether or not tumor can be identified ex vivo on breast cancer specimens as compared to post-surgical histology conclusions. | One week after surgery |
Countries
United States
Outcome results
None listed