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Safety of use of the ENDOSWIR near-infrared optical imaging device on human tissues: prospective blind study
Noemie Dutrieux1,2,3, Patricia Le Coupanec4,5, Hugo Gil2,6
1Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Grenoble Alpes University Hospital, Grenoble, France.
Abstract:
Cancer surgery requires removing the tumor tissue in necessary and sufficient quantities. Spectral optical imaging in the short-wave infrared (900-1700 nm) could provide an intraoperative guidance to the surgeon based on the absorption of the tissues without contrast agent. Our objective was to ensure the safety of our ENDOSWIR device on human tissues. Histological analysis of fresh human tonsils exposed to the SWIR light or not was compared and showed no histological differences. This demonstrates the safety of using the SWIR device on human tissues and allows us to initiate a clinical study for the resection of tumors intraoperatively.
Insights
Short-wave infrared (SWIR) spectral imaging is safe for human tissues. This finding supports using the ENDOSWIR device for real-time cancer surgery guidance without contrast agents.
Area of Science:
- Medical imaging
- Surgical oncology
- Biophotonics
Background:
- Accurate tumor removal is critical in cancer surgery.
- Spectral optical imaging offers potential for intraoperative guidance.
- Short-wave infrared (SWIR) imaging (900-1700 nm) can differentiate tissues based on absorption without contrast agents.
Purpose of the Study:
- To evaluate the safety of the ENDOSWIR device utilizing SWIR light on human tissues.
- To determine if SWIR light exposure causes histological damage.
Main Methods:
- Fresh human tonsil tissues were used for safety assessment.
- Histological analysis was performed on tissues exposed to SWIR light and control tissues.
- Comparison of histological findings between exposed and unexposed tissues.
Main Results:
- No significant histological differences were observed between human tonsil tissues exposed to SWIR light and those not exposed.
- The histological analysis confirmed the absence of damage caused by the ENDOSWIR device's SWIR light.
Conclusions:
- The ENDOSWIR device is safe for use on human tissues.
- These safety findings validate the initiation of a clinical study for intraoperative tumor resection guidance using SWIR imaging.
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