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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Magdalena Bogdanovska Todorovska, MD, PhD
- 電話番号：+389-70960221
- メール：magdalena.todorovska@medf.ukim.edu.mk
研究連絡先のバックアップ
- 名前：Borislav Kondov, MD, PhD
- 電話番号：+389.72539003
- メール：borislav.kondov@medf.ukim.edu.mk
研究場所
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Skopje、北マケドニア、1000
- University Clinic Hospital
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コンタクト：
- Magdalena Bogdanovska Todorovska, MD, PhD
- 電話番号：+389.70.960221
- メール：magdalena.todorovska@medf.ukim.edu.mk
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主任研究者：
- Magdalena Bogdanovska Todorovska, MD, PhD
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副調査官：
- Borislav Kondov, MD, PhD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative Day 1 Biochemical Hypocalcemia
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Early Intact Parathyroid Hormone
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Magdalena Bogdanovska Todorovska, MD, PhD、Ss. Cyril and Methodius University of Skopje
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 02-2848/10
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IPD プランの説明
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