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NIRAF-Guided Parathyroid Identification During Thyroidectomy

29 mei 2026 bijgewerkt door: Prof. Magdalena Bogdanovska Todorovska, Ss. Cyril and Methodius University of Skopje

Near-Infrared Autofluorescence-Guided Parathyroid Identification During Thyroidectomy

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Near-infrared autofluorescence (NIRAF) imaging is being evaluated as a structured adjunct to standard thyroidectomy for localization and preservation of parathyroid tissue. Parathyroid tissue emits intrinsic near-infrared autofluorescence without administration of dye or other contrast agent. The study imaging platform is a modified head-mounted stereoscopic goggle system that provides near-infrared excitation at approximately 780 nm and detects autofluorescence centered near 800 nm. Imaging is non-contact and is performed only during a brief prespecified in vivo mapping interval and ex vivo back-table specimen interrogation.

The study includes a run-in validation component followed by a randomized interventional component. In the run-in component, ex vivo imaging of thyroidectomy specimens is used to standardize imaging conditions, documentation, suture marking, specimen mapping, and pathology correlation for NIRAF-positive foci. In the randomized component, participants undergoing total or completion thyroidectomy are randomized to standard surgery or standard surgery plus adjunct NIRAF mapping. In the intervention arm, the surgeon records parathyroid glands identified under white light before mapping, then uses NIRAF information as an adjunct to standard anatomy and surgical judgment. After thyroid removal, ex vivo specimen imaging may be used to identify NIRAF-bright foci that could represent inadvertently excised parathyroid tissue. Rescue autotransplantation may be performed only when clinically appropriate and oncologically safe.

NIRAF findings are intended to supplement, not replace, standard operative assessment, surgical anatomy, pathology review, or oncologic decision-making.

Studietype

Ingrijpend

Inschrijving (Geschat)

280

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Noord-Macedonië
      • Skopje, Noord-Macedonië, 1000
        • University Clinic Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Magdalena Bogdanovska Todorovska, MD, PhD
        • Onderonderzoeker:
          • Borislav Kondov, MD, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.
  • Willingness to comply with routine postoperative laboratory testing and follow-up when feasible.

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Standard Thyroidectomy
Participants undergo standard thyroidectomy under white light and routine surgical judgment. Conventional autotransplantation remains permitted if the surgeon identifies a devascularized or inadvertently excised parathyroid gland by standard methods.
Experimenteel: Standard Thyroidectomy Plus NIRAF-Guided Parathyroid Mapping
Participants undergo standard thyroidectomy plus a defined interval of in vivo near-infrared autofluorescence (NIRAF) mapping after thyroid exposure and ex vivo interrogation of the resected thyroid specimen. Rescue autotransplantation may be performed when a NIRAF-bright focus on the specimen is judged likely to represent parathyroid tissue and meets predefined oncologic safety criteria.
Apparaat: Wearable Near-Infrared Autofluorescence Imaging System
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative Day 1 Biochemical Hypocalcemia
Tijdsspanne: Postoperative Day 1
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.
Postoperative Day 1

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Early Intact Parathyroid Hormone
Tijdsspanne: 2 to 4 hours postoperatively, with optional assessment on Postoperative Day 1
Early intact parathyroid hormone concentration used as an acute physiologic correlate of in situ parathyroid gland function.
2 to 4 hours postoperatively, with optional assessment on Postoperative Day 1
Mapping Yield
Tijdsspanne: Intraoperative
Number of parathyroid-consistent NIRAF sites identified during the intraoperative mapping interval.
Intraoperative
Additional NIRAF Sites Beyond White-Light Assessment
Tijdsspanne: Intraoperative
Number of NIRAF sites identified that were not included in the surgeon's pre-mapping white-light declaration.
Intraoperative
Mapping Efficiency
Tijdsspanne: Intraoperative
Time to first parathyroid identification with NIRAF imaging and total duration of the intraoperative mapping interval.
Intraoperative
Incidental Parathyroid Tissue in the Thyroidectomy Specimen
Tijdsspanne: Postoperative pathology review (up to 30 days postoperatively)
Presence and number of histologically confirmed parathyroid glands or parathyroid tissue fragments identified in the thyroidectomy specimen, including size when feasible. The number of confirmed parathyroid glands or tissue foci may be summarized categorically as 0, 1, 2, 3, or 4 when applicable.
Postoperative pathology review (up to 30 days postoperatively)
Rescue Autotransplantation Events
Tijdsspanne: Intraoperative
Whether rescue autotransplantation was performed, including tissue source, implant site, and number of fragments implanted.
Intraoperative
Longer-Term Albumin-Corrected Serum Calcium
Tijdsspanne: Postoperative week 8 and postoperative month 6
Albumin-corrected total serum calcium concentration measured at postoperative follow-up.
Postoperative week 8 and postoperative month 6
Longer-Term Intact Parathyroid Hormone
Tijdsspanne: Postoperative week 8 and postoperative month 6
Serum intact parathyroid hormone concentration measured at postoperative follow-up.
Postoperative week 8 and postoperative month 6
Calcium or Calcitriol Supplementation at Follow-Up
Tijdsspanne: Postoperative week 8 and postoperative month 6
Use of oral calcium and/or calcitriol supplementation at postoperative follow-up.
Postoperative week 8 and postoperative month 6

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ss. Cyril and Methodius University of Skopje

Medewerkers

University of Illinois at Urbana-Champaign

Onderzoekers

  • Hoofdonderzoeker: Magdalena Bogdanovska Todorovska, MD, PhD, Ss. Cyril and Methodius University of Skopje

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 juni 2029

Studie voltooiing (Geschat)

1 december 2029

Studieregistratiedata

Eerst ingediend

21 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 02-2848/10

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

No individual participant data will be shared with outside researchers. Deidentified aggregate study results may be reported in scientific presentations and publications.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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