Health Trials

NIRAF-Guided Parathyroid Identification During Thyroidectomy

ConditionsHypocalcemiaHypoparathyroidismThyroid DiseasesGoiter, NodularThyroid NoduleThyroidectomy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Wearable Near-Infrared Autofluorescence Imaging System

    Device

    A modified Meta head-mounted stereoscopic goggle system configured for label-free near-infrared autofluorescence imaging. The system delivers near-infrared excitation at approximately 780 nm and detects parathyroid autofluorescence centered near 800 nm. No injected dye or external contrast agent is administered. The device is used briefly after thyroid exposure for in vivo mapping and after thyroid resection for ex vivo specimen interrogation.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Standard ThyroidectomyNo intervention 0 interventions
Group B: Standard Thyroidectomy Plus NIRAF-Guided Parathyroid MappingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Day 1 Biochemical Hypocalcemia

Proportion of randomized Component B participants with transient biochemical hypocalcemia on postoperative day 1, defined as albumin-corrected total serum calcium below the lower limit of the institutional clinical laboratory reference range in use at study activation.

Time frame
Postoperative Day 1

Secondary outcomes

1

Early Intact Parathyroid Hormone

Early intact parathyroid hormone concentration used as an acute physiologic correlate of in situ parathyroid gland function.

Time frame
2 to 4 hours postoperatively, with optional assessment on Postoperative Day 1
2

Mapping Yield

Number of parathyroid-consistent NIRAF sites identified during the intraoperative mapping interval.

Time frame
Intraoperative
3

Additional NIRAF Sites Beyond White-Light Assessment

Number of NIRAF sites identified that were not included in the surgeon's pre-mapping white-light declaration.

Time frame
Intraoperative
4

Mapping Efficiency

Time to first parathyroid identification with NIRAF imaging and total duration of the intraoperative mapping interval.

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ss. Cyril and Methodius University of Skopje

Lead sponsor

University of Illinois at Urbana-Champaign

Collaborator

Source ClinicalTrials.gov

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