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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.
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.
Observational Model: Cohort, Time Perspective: Prospective
Optical Coherence Tomography
Carle Foundation Hospital
Diagnostic Photonics, Inc.
Published on BioPortfolio: 2014-08-27T04:00:30-0400
Optical Coherence Tomography (OCT) is a relatively new imaging technique in ophthalmology. This clear and documented imaging identified new diseases/ observations that were not previously ...
Objectives: 1. To assess the tolerability of performing optical coherence tomography and/or optical spectroscopy in patients with acute oral mucositis. 2. To determine the...
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A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
Track and monitor developments in breast cancer research and commercial development. Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...
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