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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Magdalena Bogdanovska Todorovska, MD, PhD
- 전화번호: +389-70960221
- 이메일: magdalena.todorovska@medf.ukim.edu.mk
연구 연락처 백업
- 이름: Borislav Kondov, MD, PhD
- 전화번호: +389.72539003
- 이메일: borislav.kondov@medf.ukim.edu.mk
연구 장소
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Skopje, 북 마케도니아, 1000
- University Clinic Hospital
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연락하다:
- Magdalena Bogdanovska Todorovska, MD, PhD
- 전화번호: +389.70.960221
- 이메일: magdalena.todorovska@medf.ukim.edu.mk
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수석 연구원:
- Magdalena Bogdanovska Todorovska, MD, PhD
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부수사관:
- Borislav Kondov, MD, PhD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Day 1 Biochemical Hypocalcemia
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Early Intact Parathyroid Hormone
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Magdalena Bogdanovska Todorovska, MD, PhD, Ss. Cyril and Methodius University of Skopje
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 02-2848/10
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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