NIRAF-Guided Parathyroid Identification During Thyroidectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSs. Cyril and Methodius University of Skopje
About this trial
This is a single-site, two-component prospective study evaluating whether near-infrared autofluorescence (NIRAF) imaging can improve intraoperative identification of parathyroid glands during thyroidectomy and reduce postoperative hypocalcemia.
The investigational platform is a modified wearable stereoscopic goggle system configured for label-free NIRAF imaging. Parathyroid tissue is excited with near-infrared light at approximately 780 nm and emits autofluorescence centered near 800 nm. No injected dye or external contrast agent is used. The goggles are used only during a brief mapping interval after thyroid exposure and for ex vivo interrogation of the resected thyroid specimen.
Component A is a prospective observational run-in validation cohort of 30 adults undergoing thyroidectomy of any extent. NIRAF-positive foci on the intact thyroidectomy specimen are suture-marked and correlated with targeted pathology.
Component B is a randomized clinical study of 250 adults undergoing total or completion thyroidectomy. Participants are randomized 1:1 to standard surgery or standard surgery plus brief in vivo NIRAF mapping, ex vivo specimen interrogation, and rescue autotransplantation when indicated. The primary outcome for Component B is transient biochemical hypocalcemia on postoperative day 1, defined using albumin-corrected serum calcium.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Wearable Near-Infrared Autofluorescence Imaging System
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ss. Cyril and Methodius University of Skopje
Lead sponsor
University of Illinois at Urbana-Champaign
Collaborator
Source ClinicalTrials.gov