NIRAF-Guided Parathyroid Identification During Thyroidectomy

NCT07617584 | Not Yet Recruiting

• 1 other identifier: 02-2848/10
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypocalcemia; Hypoparathyroidism; Thyroid Diseases; Goiter, Nodular; Thyroid Nodule; Thyroidectomy

Keywords

Near-Infrared Autofluorescence; NIRAF; Parathyroid Identification; Parathyroid Preservation; Thyroidectomy; Completion Thyroidectomy; Total Thyroidectomy; Postoperative Hypocalcemia; Intact Parathyroid Hormone; iPTH; Rescue Autotransplantation; Wearable Imaging; Post-thyroidectomy hypocalcemia

Outcome Measures

Primary Outcomes (1)

• Postoperative Day 1 Biochemical Hypocalcemia

  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

Secondary Outcomes (9)

• Early Intact Parathyroid Hormone

  2 to 4 hours postoperatively, with optional assessment on Postoperative Day 1

• Mapping Yield

  Intraoperative

• Additional NIRAF Sites Beyond White-Light Assessment

  Intraoperative

• Mapping Efficiency

  Intraoperative

• Incidental Parathyroid Tissue in the Thyroidectomy Specimen

  Postoperative pathology review (up to 30 days postoperatively)

Study Arms (2)

Standard Thyroidectomy

NO INTERVENTION

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.

Standard Thyroidectomy Plus NIRAF-Guided Parathyroid Mapping

EXPERIMENTAL

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.

Device: Wearable Near-Infrared Autofluorescence Imaging System

Interventions

Wearable Near-Infrared Autofluorescence Imaging System DEVICE

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.

Standard Thyroidectomy Plus NIRAF-Guided Parathyroid Mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ss. Cyril and Methodius University of Skopje: lead
• University of Illinois at Urbana-Champaign: collaborator

Study Sites (1)

University Clinic Hospital

Skopje, 1000, North Macedonia

Location

Related Publications (3)

• 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.

  PMID: 39104194 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hypocalcemia; Hypoparathyroidism; Thyroid Diseases; Goiter, Nodular; Thyroid Nodule

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Parathyroid Diseases; Endocrine System Diseases; Goiter; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Magdalena Bogdanovska Todorovska, MD, PhD

  Ss. Cyril and Methodius University of Skopje

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Bogdanovska Todorovska, MD, PhD

CONTACT

+389-70960221; magdalena.todorovska@medf.ukim.edu.mk

Borislav Kondov, MD, PhD

CONTACT

+389.72539003; borislav.kondov@medf.ukim.edu.mk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is open label. Blinding of the operating surgeon is not feasible because the intervention involves intraoperative use of the NIRAF imaging device. Laboratory values and pathology findings are objective outcomes and will be analyzed using prespecified definitions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Principal Investigator

Model Details: This study includes two linked components. Component A is a prospective observational run-in validation cohort of 30 participants undergoing thyroidectomy of any extent. Component B is a prospective randomized parallel-group study of 250 participants undergoing total or completion thyroidectomy. Component B 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)