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NIRAF-Guided Parathyroid Identification During Thyroidectomy

29. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

280

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Nordmakedonien
      • Skopje, Nordmakedonien, 1000
        • University Clinic Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Magdalena Bogdanovska Todorovska, MD, PhD
        • Underforsker:
          • Borislav Kondov, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

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  • Voksen
  • Ældre voksen

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Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Day 1 Biochemical Hypocalcemia
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Early Intact Parathyroid Hormone
Tidsramme: 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
Tidsramme: Intraoperative
Number of parathyroid-consistent NIRAF sites identified during the intraoperative mapping interval.
Intraoperative
Additional NIRAF Sites Beyond White-Light Assessment
Tidsramme: Intraoperative
Number of NIRAF sites identified that were not included in the surgeon's pre-mapping white-light declaration.
Intraoperative
Mapping Efficiency
Tidsramme: 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
Tidsramme: 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
Tidsramme: Intraoperative
Whether rescue autotransplantation was performed, including tissue source, implant site, and number of fragments implanted.
Intraoperative
Longer-Term Albumin-Corrected Serum Calcium
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

Ss. Cyril and Methodius University of Skopje

Samarbejdspartnere

University of Illinois at Urbana-Champaign

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2029

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 02-2848/10

Plan for individuelle deltagerdata (IPD)

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IPD-planbeskrivelse

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

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