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Evaluation of Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma
The NIR light source of our device is based on light-emitting diodes (LEDs), which can deliver sufficient light to biological tissues and induce fluorescence emission to meet the needs of the planned clinical studies. It should be noted that the light source is still well under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the light source is not laser-based, which is significantly safer than other optical imaging systems utilizing laser technologies. The fluorescence signals will be received by the detector portion of our device. Gain-settings could be easily adjusted during operation to optimize the contrast between high fluorescence areas (tumors) and low fluorescence areas (normal tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as well as on a secondary monitor to facilitate viewing by other surgeons in the room.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Washington University School of Medicine
St Louis, Missouri, United States
Start Date
February 1, 2014
Primary Completion Date
June 1, 2015
Completion Date
December 1, 2015
Last Updated
September 24, 2019
20
ACTUAL participants
Sentinel lymph node biopsy
PROCEDURE
Goggle-based device with light-emitting diodes (LED)
DEVICE
Indocynanine Green
DRUG
Lead Sponsor
Washington University School of Medicine
NCT04550494
NCT05673200
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