Handheld projective imaging device for near-infrared fluorescence imaging and intraoperative guidance of sentinel lymph node resection

Abstract. We propose a handheld projective imaging device for orthotopic projection of near-infrared fluorescence images onto target biological tissue at visible wavelengths without any additional visual aid. The device integrates a laser diode light source module, a camera module, a projector, an ultrasonic distance sensor, a Raspberry Pi single-board computer, and a battery module in a rugged handheld unit. It is calibrated at the detected working distance for seamless coregistration between fluorescence emission and projective imaging at the target tissue site. The proposed device is able to achieve a projection resolution higher than 314  μm and a planar projection bias less than 1 mm at a projection field of view of 58×108  mm2 and a working distance of 27 cm. Technical feasibility for projective imaging is verified in an ex vivo model of chicken breast tissue using indocyanine green as a fluorescence agent. Clinical utility for image-guided surgery is demonstrated in a clinical trial where sentinel lymph nodes in breast cancer patients are identified and resected under the guidance of projective imaging. Our ex vivo and in vivo experiments imply the clinical utility of deploying the proposed device for image-guided surgical interventions in resource-limited settings.

[1]  A. Hartz,et al.  A comparison of observational studies and randomized, controlled trials. , 2000, The New England journal of medicine.

[2]  I-Chih Tan,et al.  Lymphatic imaging in humans with near-infrared fluorescence. , 2009, Current opinion in biotechnology.

[3]  Brian W Pogue,et al.  Review of fluorescence guided surgery systems: identification of key performance capabilities beyond indocyanine green imaging , 2016, Journal of biomedical optics.

[4]  E. Winer,et al.  American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. , 2005, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[5]  E M Sevick-Muraca,et al.  Translation of near-infrared fluorescence imaging technologies: emerging clinical applications. , 2012, Annual review of medicine.

[6]  Chuanzhen Hu,et al.  Benchtop and Animal Validation of a Projective Imaging System for Potential Use in Intraoperative Surgical Guidance , 2016, PloS one.

[7]  Matthew P. Goetz,et al.  NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY , 2019 .

[8]  H. Kuerer,et al.  Trends in and Outcomes from Sentinel Lymph Node Biopsy (SLNB) Alone vs. SLNB with Axillary Lymph Node Dissection for Node-Positive Breast Cancer Patients: Experience from the SEER Database , 2010, Annals of Surgical Oncology.

[9]  R. Simmons,et al.  Methylene blue dye as an alternative to isosulfan blue dye for sentinel lymph node localization. , 2003, The breast journal.

[10]  Samuel Achilefu,et al.  Dynamic optical projection of acquired luminescence for aiding oncologic surgery , 2013, Journal of biomedical optics.