Translating near infrared autofluorescence for guiding pediatric endocrine neck surgeries

Vanderbilt University received a $1,000,028 Project Grant from the National Institute of Child Health and Human Development under the Child Health and Human Development Extramural Research program (CFDA 93.865), awarded September 1, 2025, with completion targeted for August 31, 2027. The project addresses post-operative hypoparathyroidism (POSH) and hypocalcemia complications in pediatric thyroidectomy patients by translating near infrared autofluorescence (NIRAF) technology for clinical use in this vulnerable population. The research will characterize the spectral properties of pediatric parathyroid gland tissue at five high-volume pediatric thyroidectomy centers, interrogate NIRAF signal variation using parathyroid gland organoids, and modify the FDA-cleared PTEYE device (marketed by Medtronic) to optimize detection metrics for pediatric patients before clinical deployment to evaluate short- and long-term surgical outcomes.

Vanderbilt University Medical Center serves as a key sub-awardee, with clinical leadership from Dr. Monica Lopez and Dr. Ryan Belcher, who will collect fluorescence spectra from pediatric neck tissues during thyroidectomy procedures at Vanderbilt University Medical Center. The sub-awardee team is responsible for ensuring measurement integrity, training operating room staff, and managing clinical data collection to support the technology translation objectives outlined in the three-aim research plan.

Abstract

This proposal aims to address the rate of hypocalcemia following thyroidectomy in the pediatric population using near infrared autofluorescence (niraf) of parathyroid glands. Thyroid cancer is one of the most common cancers affecting adolescents and young adults and permanent hypoparathyroidism is the most frequently reported complication following thyroidectomy. Post-operative hypoparathyroidism (posh), resulting from damage to the parathyroid glands or their vasculature, gives rise to hypocalcemia in 30-50% of cases transiently and up to 7% permanently. We have developed an approach based on niraf exhibited by the parathyroid glands and demonstrated clinical utility by showing that 97% of parathyroid glands have greater autofluorescence than surrounding tissues. The lab-built system used in these studies has since been commercialized as the FDA cleared pteye® marketed by medtronic. However, additional work has shown the autofluorescence from other neck tissues are more variable in the pediatric population, causing a higher false positive rate. Here, we propose a rigorous evaluation of the autofluorescence of pediatric neck tissues to aid in the specific translation of this technology to pediatric neck surgeries by tailoring the metrics used for this new patient population. To achieve this, we will characterize the spectral properties of parathyroid gland tissue in children (aim 1) at five of the nation's high-volume centers for pediatric thyroidectomies. The variation of niraf over time in the pediatric population will then be interrogated using parathyroid gland organoids (aim 2) to better understand the underpinnings of the fluorescence signal. Finally, the findings from aims 1 and 2 will be used to modify the pteye® before deploying IT in the clinic to characterize the short- and long-term outcomes of pediatric thyroidectomy among high-volume centers (aim 3). Because this will be the first multi-center prospective study for pediatric thyroidectomies, aim 3 will also serve to standardize the perioperative care and clinical outcome definitions, as current practice is extrapolated from adult procedures without pediatric-specific clinical standards.