First-in-human clinical trials of imaging devices: an example from optical imaging.
Clinical translation of scientific discoveries is often the long-term goal of academic medical research. However, this goal is not always realized due to the complicated path between bench research and clinical use. In this review, we outline the fundamental steps required for first-in-human testing of a new imaging device, and use the FLARE() (Fluorescence-Assisted Resection and Exploration) near-infrared fluorescence optical imaging platform as an example.
Gibbs-Strauss
Summer L
SL
Department of Radiology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Room SL-B05, Boston, MA 02215, USA.
Rosenberg
Mireille
M
Clough
Barbara L
BL
Troyan
Susan L
SL
Frangioni
John V
JV
D000818:Animals; D035843:Biomedical Research / Q000592:standards / Q000639:trends; D002986:Clinical Trials as Topic; D003952:Diagnostic Imaging / Q000592:standards / Q000639:trends*; D004867:Equipment Design; D006801:Humans; D008279:Magnetic Resonance Imaging; D055095:Optics and Photonics; D049268:Positron-Emission Tomography; D011785:Quality Assurance, Health Care; D019265:Spectroscopy, Near-Infrared / Q000379:methods; D015899:Tomography, Emission-Computed, Single-Photon; D014463:Ultrasonography; D014965:X-Rays