NIRAF-Guided Parathyroid Identification During Thyroidectomy
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Magdalena Bogdanovska Todorovska, MD, PhD
- Numer telefonu: +389-70960221
- E-mail: magdalena.todorovska@medf.ukim.edu.mk
Kopia zapasowa kontaktu do badania
- Nazwa: Borislav Kondov, MD, PhD
- Numer telefonu: +389.72539003
- E-mail: borislav.kondov@medf.ukim.edu.mk
Lokalizacje studiów
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Skopje, Macedonia Północna, 1000
- University Clinic Hospital
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Kontakt:
- Magdalena Bogdanovska Todorovska, MD, PhD
- Numer telefonu: +389.70.960221
- E-mail: magdalena.todorovska@medf.ukim.edu.mk
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Główny śledczy:
- Magdalena Bogdanovska Todorovska, MD, PhD
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Pod-śledczy:
- Borislav Kondov, MD, PhD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: 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.
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Eksperymentalny: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Postoperative Day 1 Biochemical Hypocalcemia
Ramy czasowe: Postoperative Day 1
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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.
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Postoperative Day 1
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Early Intact Parathyroid Hormone
Ramy czasowe: 2 to 4 hours postoperatively, with optional assessment on Postoperative Day 1
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Early intact parathyroid hormone concentration used as an acute physiologic correlate of in situ parathyroid gland function.
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2 to 4 hours postoperatively, with optional assessment on Postoperative Day 1
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Mapping Yield
Ramy czasowe: Intraoperative
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Number of parathyroid-consistent NIRAF sites identified during the intraoperative mapping interval.
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Intraoperative
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Additional NIRAF Sites Beyond White-Light Assessment
Ramy czasowe: Intraoperative
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Number of NIRAF sites identified that were not included in the surgeon's pre-mapping white-light declaration.
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Intraoperative
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Mapping Efficiency
Ramy czasowe: Intraoperative
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Time to first parathyroid identification with NIRAF imaging and total duration of the intraoperative mapping interval.
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Intraoperative
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Incidental Parathyroid Tissue in the Thyroidectomy Specimen
Ramy czasowe: Postoperative pathology review (up to 30 days postoperatively)
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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.
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Postoperative pathology review (up to 30 days postoperatively)
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Rescue Autotransplantation Events
Ramy czasowe: Intraoperative
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Whether rescue autotransplantation was performed, including tissue source, implant site, and number of fragments implanted.
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Intraoperative
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Longer-Term Albumin-Corrected Serum Calcium
Ramy czasowe: Postoperative week 8 and postoperative month 6
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Albumin-corrected total serum calcium concentration measured at postoperative follow-up.
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Postoperative week 8 and postoperative month 6
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Longer-Term Intact Parathyroid Hormone
Ramy czasowe: Postoperative week 8 and postoperative month 6
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Serum intact parathyroid hormone concentration measured at postoperative follow-up.
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Postoperative week 8 and postoperative month 6
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Calcium or Calcitriol Supplementation at Follow-Up
Ramy czasowe: Postoperative week 8 and postoperative month 6
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Use of oral calcium and/or calcitriol supplementation at postoperative follow-up.
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Postoperative week 8 and postoperative month 6
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Magdalena Bogdanovska Todorovska, MD, PhD, Ss. Cyril and Methodius University of Skopje
Publikacje i pomocne linki
Publikacje ogólne
- Benmiloud F, Godiris-Petit G, Gras R, Gillot JC, Turrin N, Penaranda G, Noullet S, Chereau N, Gaudart J, Chiche L, Rebaudet S. Association of Autofluorescence-Based Detection of the Parathyroid Glands During Total Thyroidectomy With Postoperative Hypocalcemia Risk: Results of the PARAFLUO Multicenter Randomized Clinical Trial. JAMA Surg. 2020 Feb 1;155(2):106-112. doi: 10.1001/jamasurg.2019.4613.
- Canali L, Russell MD, Sistovaris A, Abdelhamid Ahmed AH, Otremba M, Tierney HT, Triponez F, Benmiloud F, Spriano G, Mercante G, Randolph GW. Camera-based near-infrared autofluorescence versus visual identification in total thyroidectomy for parathyroid function preservation: Systematic review and meta-analysis of randomized clinical trials. Head Neck. 2025 Jan;47(1):225-234. doi: 10.1002/hed.27900. Epub 2024 Aug 5.
- Kim DH, Kim SW, Kang P, Choi J, Lee HS, Park SY, Kim Y, Ahn YC, Lee KD. Near-Infrared Autofluorescence Imaging May Reduce Temporary Hypoparathyroidism in Patients Undergoing Total Thyroidectomy and Central Neck Dissection. Thyroid. 2021 Sep;31(9):1400-1408. doi: 10.1089/thy.2021.0056. Epub 2021 Jun 4.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
- Wycięcie tarczycy
- Całkowita tyreoidektomia
- Hipokalcemia pooperacyjna
- NIRAF
- ipth
- Identyfikacja przytarczyc
- Autofluorescencja w bliskiej podczerwieni
- Obrazowanie Noszone
- Parathyroid Preservation
- Completion Thyroidectomy
- Intact Parathyroid Hormone
- Rescue Autotransplantation
- Post-thyroidectomy hypocalcemia
Dodatkowe istotne warunki MeSH
- Choroby układu hormonalnego
- Nowotwory według lokalizacji
- Nowotwory
- Choroby metaboliczne
- Nowotwory tarczycy
- Nowotwory gruczołów dokrewnych
- Nowotwory głowy i szyi
- Brak równowagi wodno-elektrolitowej
- Choroby przytarczyc
- Wole
- Zaburzenia metabolizmu wapnia
- Choroby żywieniowe i metaboliczne
- Choroby tarczycy
- Guzek tarczycy
- Wole guzkowe
- Niedoczynność przytarczyc
- Hipokalcemia
Inne numery identyfikacyjne badania
- 02-2848/10
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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