A standalone non-invasive non-contact portable diagnostic device for detection and identification of cancer margins based on anomalous vascularization and thermal behavior, usable in real-time for pre-/intra-/postoperative patient-specific incessant diagnosis.
Current approaches to cancer diagnostics often rely on expensive equipment that requires high skill and cost to operate, factors that come at the expense of healthcare institutions and patients alike. Most critically, diagnostic equipment such as MRI and CT devices cannot be used intraoperatively, on account of bulky equipment, pathological concerns in the case of exposed tissue, as well as radiological concerns due to radiation limits. In all of the existing diagnostic techniques, diagnoses take time to be developed, often by a specialist and in conjunction with laboratory biopsy analysis. This is a lengthy and costly process, requiring multiple patient visits that come with their respective doses of radiation and blood draws, which naturally require adequate hospital infrastructure and prolonged patient stays.
We propose a novel non-invasive, non-contact, portable diagnostic devices that allows for real-time pre-/intra-/postoperative incessant diagnosis of cancer margins. The device requires no cloud computing, no lab diagnosis, and low operator skill, allowing it to be deployed in low-infrastructure remote healthcare settings at low operating cost. Our device, called the Calisone Sondo, is based on a combination of active and passive near infrared (NIR) and visual (VIS) sensing techniques. In the first of two near-infrared windows in biological tissue, NIR-I (760-900 nm), where NIR penetration depth is greater than usual, we use active low-power IR illumination to detect anomalous vascularization through shallow surface angiography. The same technique, when coupled with FDA-approved NIR biofluorescent dyes such as indocyanine green (ICG), allows for active illumination of tumor masses at unprecedented levels of accuracy, an approach that is currently used to actively delineate cancers masses during resection surgery. Both of these techniques in NIR-I suffer from a limitation in penetration depth in the order of 10-20 mm; to detect and characterize deeper cancer masses, which are often the most insidious and least detected, beyond conventional means, we propose a novel approach based on active laser thermography in the second NIR window (NIR-II; 1000-1700 nm). The novel advancement here is to elevate subsurface tissue temperatures in a point-focused manner using a focused NIR laser beam (Nd:YAG laser at 1064 nm), elevating ever so slightly the subsurface temperature and detecting the response using surface thermography with a miniature thermal camera. This novel technique, akin to confocal microscopy, allows us to detect tissue anomalies by leveraging fundamental biophysics and biotissue thermodynamics, a patient-specific diagnosis technique developed by one of the proposers that has garnered critical acclaim in the biomedical engineering research community.
The complete device is as small as a handheld tablet and is completely wireless and standalone, making it ideal for use in field applications as well as in underserved and low-infrastructure healthcare settings. In such settings, referrals to larger hospitals are costly, and most patients are un- or underinsured. The Calisone Sondo's small footprint and high-fidelity non-invasive non-contact diagnostic capabilities are on par or exceed those of dedicated diagnostic devices that do not allow for interoperability and data fusion for patient specific diagnostics, opening up an entirely new realm for low-cost rapid patient-specific cancer diagnostics.