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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Magdalena Bogdanovska Todorovska, MD, PhD
- Номер телефона: +389-70960221
- Электронная почта: magdalena.todorovska@medf.ukim.edu.mk
Учебное резервное копирование контактов
- Имя: Borislav Kondov, MD, PhD
- Номер телефона: +389.72539003
- Электронная почта: borislav.kondov@medf.ukim.edu.mk
Места учебы
-
-
-
Skopje, Северная Македония, 1000
- University Clinic Hospital
-
Контакт:
- Magdalena Bogdanovska Todorovska, MD, PhD
- Номер телефона: +389.70.960221
- Электронная почта: magdalena.todorovska@medf.ukim.edu.mk
-
Главный следователь:
- Magdalena Bogdanovska Todorovska, MD, PhD
-
Младший исследователь:
- Borislav Kondov, MD, PhD
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: 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.
|
|
|
Экспериментальный: 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.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Postoperative Day 1 Biochemical Hypocalcemia
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Early Intact Parathyroid Hormone
Временное ограничение: 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
Временное ограничение: Intraoperative
|
Number of parathyroid-consistent NIRAF sites identified during the intraoperative mapping interval.
|
Intraoperative
|
|
Additional NIRAF Sites Beyond White-Light Assessment
Временное ограничение: Intraoperative
|
Number of NIRAF sites identified that were not included in the surgeon's pre-mapping white-light declaration.
|
Intraoperative
|
|
Mapping Efficiency
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Intraoperative
|
Whether rescue autotransplantation was performed, including tissue source, implant site, and number of fragments implanted.
|
Intraoperative
|
|
Longer-Term Albumin-Corrected Serum Calcium
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Следователи
- Главный следователь: Magdalena Bogdanovska Todorovska, MD, PhD, Ss. Cyril and Methodius University of Skopje
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
- Тиреоидэктомия
- Тотальная тиреоидэктомия
- Послеоперационная гипокальциемия
- НИРАФ
- IPTH
- Идентификация околощитовидной железы
- Аутофлуоресценция почти инфракрасных
- Носимая визуализация
- Parathyroid Preservation
- Completion Thyroidectomy
- Intact Parathyroid Hormone
- Rescue Autotransplantation
- Post-thyroidectomy hypocalcemia
Дополнительные соответствующие термины MeSH
- Заболевания эндокринной системы
- Новообразования по локализации
- Новообразования
- Метаболические заболевания
- Новообразования щитовидной железы
- Новообразования эндокринных желез
- Новообразования головы и шеи
- Водно-электролитный дисбаланс
- Заболевания паращитовидной железы
- Зоб
- Нарушения обмена кальция
- Пищевые и метаболические заболевания
- Заболевания щитовидной железы
- Узел щитовидной железы
- Зоб, Узловой
- Гипопаратиреоз
- Гипокальциемия
Другие идентификационные номера исследования
- 02-2848/10
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .