By Jill Clendening
A team led by Vanderbilt University and Vanderbilt University Medical Center biomedical engineers and surgeons has published results of a large clinical trial showing that use of a near-infrared autofluorescence (NIRAF) probe device improves interoperative identification of parathyroid glands (PGs).
The biomedical engineers and surgeons published results of the first multicenter, randomized clinical trial using this technology during endocrine neck procedures in JAMA Surgery.
While endocrine neck surgery is generally safe with a low rate of complications, inadvertent removal and damage to PGs can cause hypoparathyroidism, a condition that can lead to low levels of calcium and elevated levels of phosphorus in the blood. Long-term hypoparathyroidism complications include impaired kidney function, cardiac arrhythmias and increased risk of death. Because of this, it is crucial to accurately identify these glands during parathyroidectomy and thyroidectomy.
In 2018, the Food and Drug Administration granted de novo classification and marketing authorization for a device to assist with detection of parathyroid glands in adults called the PTeye, which was used in this trial. The device was developed by the Vanderbilt Biophotonics Center, led by Anita Mahadevan-Jansen, PhD, the Orrin H. Ingram Professor of Engineering. Its clinical implementation was pioneered by a group of VUMC surgeons led by Carmen Solórzano, MD, chair of the Department of Surgery, John L. Sawyers Professor of Surgical Sciences and director of Vanderbilt Endocrine Surgery.
“NIRAF technology leverages the fact that parathyroid tissue emits a stronger near-infrared autofluorescence signal than other tissues in the neck, so it glows in the surgical field when using our device,” said Mahadevan-Jansen. “Our team has been working diligently for several years to take this from concept in our lab to clinical practice. It is gratifying to now have this large, multicenter clinical trial provide further evidence of its impact in successfully and efficiently identifying PGs during surgery. It is our ultimate goal to improve the accuracy of endocrine neck surgeries, which will lead to improved patient outcomes.”