NIRAF-Guided Parathyroid Identification During Thyroidectomy

Официальное название

Near-Infrared Autofluorescence-Guided Parathyroid Identification During Thyroidectomy

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Postoperative Day 1 Biochemical Hypocalcemia [Срок оценки: Postoperative Day 1]

Вторичные конечные точки (9)

• Early Intact Parathyroid Hormone [Срок оценки: 2 to 4 hours postoperatively, with optional assessment on Postoperative Day 1]
• Mapping Yield [Срок оценки: Intraoperative]
• Additional NIRAF Sites Beyond White-Light Assessment [Срок оценки: Intraoperative]
• Mapping Efficiency [Срок оценки: Intraoperative]
• Incidental Parathyroid Tissue in the Thyroidectomy Specimen [Срок оценки: Postoperative pathology review (up to 30 days postoperatively)]
• Rescue Autotransplantation Events [Срок оценки: Intraoperative]
• Longer-Term Albumin-Corrected Serum Calcium [Срок оценки: Postoperative week 8 and postoperative month 6]
• Longer-Term Intact Parathyroid Hormone [Срок оценки: Postoperative week 8 and postoperative month 6]
• Calcium or Calcitriol Supplementation at Follow-Up [Срок оценки: Postoperative week 8 and postoperative month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

North Macedonia · 1 центр

• University Clinic Hospital — Skopje

Публикации

• 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 PMID 39104194
• 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. PMID 33906431
• 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. PMID 31693081

Идентификаторы

NCT: NCT07617584 · 02-2848/10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗