OptoCENTAL: a standardized, bench-testing platform based on phantoms for validating optical systems aimed at clinical monitoring of the placenta.

Abstract

Significance: Optical imaging and spectroscopy solutions, such as near-infrared spectroscopy (NIRS) and diffuse optical tomography, have the potential to provide compact, bedside monitoring of the placenta in the clinic, thanks to recent advancements in miniaturization and wireless wearability. This would provide neonatologists with continuous assessment of the pregnancy status in real time, as well as tools to possibly predict delivery outcomes.

Aim: Numerous challenges are associated with validating the performances of any optical system in providing the above goals, particularly the required depth sensitivity and accuracy to target the placenta in vivo. Currently, no testing procedure is available that can verify in a thorough and comparable manner the capability of a given photonic system to be successful in the clinics for placental monitoring.

Approach: We present here OptoCENTAL, a standardized platform based on multiple optical phantoms, from digital, through solid to liquid, for versatile bench testing, characterization, and validation of any photonics solution and instrumentation that aims at in vivo clinical monitoring of the human placenta.

Results: Exemplary applications of the OptoCENTAL platform on different types of optical systems, from wearable, continuous-wave devices to broadband and time-domain NIRS systems, demonstrate the flexibility of its procedures to be implemented with any setup, allowing users to compare performances across different solutions. The results also show the capability of OptoCENTAL to provide quantitative assessment of the major features required by any photonic solution for providing effective and efficient monitoring of the placenta, including basic instrument performances, quantification of monitoring accuracy, and depth sensitivity.

Conclusions: OptoCENTAL represents the first-of-a-kind effort in standardizing bench-testing and validation of optical imaging and spectroscopy methods in the framework of placental clinical applications, further advancing the translation of such modalities into hospitals, as well as toward future certification and commercialization of such technologies.