A guideline for clinicians performing clinical studies with fluorescence imaging

Abstract

Fluorescence imaging is an emerging imaging technique that has shown many benefits for clinical care. Currently, the field is in rapid clinical translation, and an unprecedented number of clinical trials are performed. Clinicians are inundated with numerous opportunities and combinations of different imaging modalities. To streamline this process, a multidisciplinary approach is needed with drug discovery, software and systems engineering, and translational medicine. Here, we discuss the main constituents of a uniform fluorescence imaging protocol to match the clinical need and ensure consistent study designs and reliable data collection in clinical trials. In an era in which the potential of fluorescence imaging has become evident, consistent conduct of studies, data analysis, and data interpretation are essential for implementation into standard of care.

Near-Infrared Fluorescence Axillary Reverse Mapping (ARM) Procedure in Invasive Breast Cancer: Relationship between Fluorescence Signal in ARM Lymph Nodes and Clinical Outcomes

“…The standardization of data acquisition during fluorescence quantification was mandatory. As described by Heeman et al in a guideline for surgeons interested in fluorescence guided surgery, the choice of the imager affects the camera’s detection sensitivity to the required dye, depth sensitivity, field illumination homogeneity, spatial and temporal resolutions and dynamic range [ 31 ]. The camera settings had to be defined prior the 103 patients’ inclusion to optimize the signal-to-noise ratio during data acquisition.…”

Special Section Guest Editorial: Tissue Phantoms to Advance Biomedical Optical Systems

“…For example, an international standard for pulse oximeters has been in existence for many years, 4 while more recent efforts have culminated in standards for cerebral oximetry 5 and functional near-infrared spectroscopy. 6 Furthermore, standardization activities for other areas, such as fluorescence imaging 7 , 8 and photoacoustic imaging 9 , 10 are also in progress. Advances in tissue phantoms benefit these efforts towards international standards in Biomedical Optics that will further boost the clinical translation of different technologies within this field.…”

“…In their Perspective article, Sterkenburg et al [https://doi.org/10.1117/1.JBO.27. 7.074704] review scientific literature relevant to standardization of this technique, including fluorescence phantoms for performance testing. The authors describe phantoms that can provide thorough image quality characterization or streamlined day-to-day testing, then conclude with a discussion of exciting new directions for this technology.…”

“…Research by Schädel-Ebner et al [https://doi.org/10.1117/1.JBO.27. 7.074702] has resulted in a tissuesimulating material for 3D printing with indocyanine-green-simulating spectral features that are highly stable. After rigorous characterization, this material was used to print anthropomorphic phantoms for rheumatoid disease imaging in the hand.…”

“…Ban et al [https://doi.org/10.1117/1.JBO.27. 7.074710] employed a subset of tests of the same three protocols (i.e., BIP, MEDPHOT, and nEUROPt) to characterize the performance of a the newly developed advanced, miniaturized, modular and wearable multi-channel timedomain functional near-infrared spectroscopy (TD-fNIRS) system for localizing and quantifying brain activation in humans. The system was shown to compare well with existing research-grade TD-fNIRS systems.…”