NIRAF-Guided Parathyroid Identification During Thyroidectomy

This study evaluates whether a wearable near-infrared autofluorescence (NIRAF) imaging system can help surgeons identify and preserve parathyroid glands during thyroid surgery. These small glands produce parathyroid hormone (PTH), which helps control blood calcium. The modified Meta Quest stereoscopic goggles display fluorescence naturally emitted by parathyroid tissue; no injected dye is used. The study has two components. Component A is a nonrandomized, 30-participant specimen-imaging and pathology-validation component. Component B is a randomized study with a target of 250 adults undergoing total or completion thyroidectomy. Participants in Component B are assigned equally to standard surgery or standard surgery with brief NIRAF imaging of the surgical field and the removed specimen. Clinically appropriate parathyroid rescue and autotransplantation are permitted. The primary randomized outcome is early biochemical hypoparathyroidism: a serum intact PTH concentration below the testing laboratory's assay-specific lower limit of normal, measured 12 to 24 hours after skin closure, with a target of 18 hours. Calcium levels, later parathyroid function, treatment requirements, surgical findings, and complications are also assessed. Follow-up lasts six months. Five research blood collections are scheduled: 1 to 2 days before surgery, 12 to 24 hours after surgery, six weeks, three months, and six months. An early safety assessment occurs 48 to 72 hours after surgery. Additional tests and visits are provided whenever clinically needed. A nested device-performance assessment records additional glands identified beyond the surgeon's initial white-light assessment and documented changes in surgical management attributable to NIRAF information. These findings are assessed separately from the randomized clinical outcomes. The revised assessment plan will be implemented following documented ethics approval of the amendment.

Inclusion Criteria: * Age 18 years or older. * For Component A: planned thyroidectomy of any extent with an intact specimen available for ex vivo evaluation. * For Component B: planned total or completion thyroidectomy. * Ability to provide written informed consent before surgery. * For Component B: willingness to undergo the scheduled laboratory assessments and follow-up through six months, in addition to clinically indicated postoperative care. Exclusion Criteria: * Known pre-existing hypoparathyroidism or prior parathyroid surgery. * Severe chronic kidney disease or end-stage renal disease expected to substantially confound calcium and parathyroid hormone interpretation, as defined by the site investigator. * Pregnancy. * For Component B only: gross nodal disease or a surgical plan requiring extensive nodal packet dissection in the current study phase. * Any condition that, in the judgment of the investigator, would make participation unsafe or compromise protocol adherence.