Challenges and opportunities in clinical translation of biomedical optical spectroscopy and imaging

Abstract

Medical devices face many hurdles before they enter routine clinical practice to address unmet clinical needs. This is also the case for biomedical optical spectroscopy and imaging systems that are used here to illustrate the opportunities and challenges involved. Following initial concept, stages in clinical translation include instrument development, preclinical testing, clinical prototyping, clinical trials, prototype-to-product conversion, regulatory approval, commercialization, and finally clinical adoption and dissemination, all in the face of potentially competing technologies. Optical technologies face additional challenges from their being extremely diverse, often targeting entirely different diseases and having orders-of-magnitude differences in resolution and tissue penetration. However, these technologies can potentially address a wide variety of unmet clinical needs since they provide rich intrinsic biochemical and structural information, have high sensitivity and specificity for disease detection and localization, and are practical, safe (minimally invasive, nonionizing), and relatively affordable.

Ensuring Scientific Publishing Credibility in Translational Biomedical Optics

“…In the field of biomedical optics, there is extreme geographic and scientific diversity, together with aspects of the work in the disparate areas of academia including medicine and industry, 22 and so it can be a challenge to promote collaboration and cooperation in this setting where successes are measured by individual events such as publishing, grant funding, and commercial triumphs. However, the features that benefit individual researchers can be the same ones that benefit the field as a whole, namely strong mentor networks of collaborative researchers, who have a healthy balance of competition and collaboration.…”

“…As money and time is spent on translational devices, hard decisions need to be made about what works, incorporating all aspects of technical performance, medical need, and commercial viability. 22 If these were all truly folded into every research program, we could likely realize improved money spent on those programs that match the needed goals and possibilities. 19,20 To achieve this, it would be good for developing researchers to have stronger mentorship and advice on where focused efforts were needed.…”

Optical and x-ray technology synergies enabling diagnostic and therapeutic applications in medicine

“…Psoralens have intrinsic nuclear uptake and, upon photoactivation, cross link to adenine and thymine residues in DNA, leading to proliferative cell death. 165 As recently suggested, 166 explicit nuclear targeting of photosensitizers combined with x-ray-generated Cherenkov or scintillation light may be particularly effective, as PDT mediated by direct light activation is known to have orders-of-magnitude greater cell kill for the same photosensitizer and light doses than when the photosensitizer is localized to extra-nuclear organelles. 167,168 This may overcome the relatively low light levels of the scintillation and Cherenkov light.…”

Photoacoustic imaging in the second near-infrared window: a review

“…9 Optical imaging modalities, including fluorescence, multiphoton fluorescence, bioluminescence, optical projection tomography, optical coherence tomography (OCT), and diffuse optical tomography (DOT), were demonstrated for in vivo animal imaging. [10][11][12] These methods used nonionizing radiation, unlike CT scan (x-ray), SPET, and PET (gamma rays), and can provide structural as well as functional information at high resolution. [13][14][15][16] However, due to the strong optical absorption and scattering of tissue, the imaging depth was limited to ∼0.1 mm (roughly the mean free path) in conventional widefield optical microscopy.…”