First-in-human pilot study of a spatial frequency domain oxygenation imaging system

Area of Science:

• Biomedical Optics
• Medical Imaging
• Surgical Technology

Background:

• Current oxygenation monitoring tools offer limited spatial coverage or are contact-based.
• Large-area tissue oxygenation visualization can enhance surgical and critical care patient management.
• A need exists for non-contact, large-area imaging of tissue oxygenation.

Purpose of the Study:

• To present a clinically compatible multispectral spatial frequency domain imaging (SFDI) system for large-area surgical oxygenation imaging.
• To validate the SFDI system's accuracy against an FDA-approved clinical oxygenation probe.
• To demonstrate the clinical applicability of SFDI in reconstructive surgery.

Main Methods:

• Development of a clinically compatible multispectral spatial frequency domain imaging (SFDI) system.
• Imaging tissue oxygenation over a 16x12 cm area in preclinical Yorkshire pig models (skin flap, bowel, liver occlusion).
• Comparison of SFDI measurements with an FDA-approved clinical oxygenation probe and a first-in-human pilot study.

Main Results:

• SFDI system accurately imaged tissue oxygenation over large areas.
• Preclinical studies showed SFDI measurements within 10% accuracy of an FDA-approved device.
• Successful pilot study demonstrated SFDI for skin flap oxygenation during breast reconstructive surgery.

Conclusions:

• The developed SFDI system is a viable tool for large-area, non-contact tissue oxygenation monitoring.
• SFDI offers accurate and clinically relevant oxygenation measurements, supporting surgical and critical care applications.
• This study establishes a foundation for the clinical translation of SFDI using endogenous contrast imaging.