HypocalcemiaNCT07617584
NIRAF-Guided Parathyroid Identification During Thyroidectomy
A study testing Wearable Near-Infrared Autofluorescence Imaging System in people with Hypocalcemia and Hypoparathyroidism, run by Ss. Cyril and Methodius University of Skopje at 1 site in North Macedonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypocalcemia, Hypoparathyroidism, Thyroid Diseases
- What is being tested?
- Wearable Near-Infrared Autofluorescence Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- 1 Jun 2026to 1 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
North Macedonia1 site
University Clinic Hospital
Skopje, 1000
Magdalena Bogdanovska Todorovska, MD, PhD, +389.70.960221, magdalena.todorovska@medf.ukim.edu.mk
Magdalena Bogdanovska Todorovska, MD, PhD
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Hypocalcemia, Hypoparathyroidism, Thyroid Diseases, Goiter, Nodular, Thyroid Nodule, Thyroidectomy
- Being tested
- Wearable Near-Infrared Autofluorescence Imaging System
- 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
- Medical subject headings
- Hypocalcemia, Hypoparathyroidism, Thyroid Diseases, Goiter, Nodular, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Near-Infrared Autofluorescence Imaging SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Wearable Near-Infrared Autofluorescence Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 1
Secondary outcomes (9)
Early Intact Parathyroid Hormone
Early intact parathyroid hormone concentration used as an acute physiologic correlate of in situ parathyroid gland function.
Measured: 2 to 4 hours postoperatively, with optional assessment on Postoperative Day 1
Mapping Yield
Number of parathyroid-consistent NIRAF sites identified during the intraoperative mapping interval.
Measured: Intraoperative
Additional NIRAF Sites Beyond White-Light Assessment
Number of NIRAF sites identified that were not included in the surgeon's pre-mapping white-light declaration.
Measured: Intraoperative
Mapping Efficiency
Time to first parathyroid identification with NIRAF imaging and total duration of the intraoperative mapping interval.
Measured: Intraoperative
Incidental Parathyroid Tissue in the Thyroidectomy Specimen
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.
Measured: Postoperative pathology review (up to 30 days postoperatively)
Rescue Autotransplantation Events
Whether rescue autotransplantation was performed, including tissue source, implant site, and number of fragments implanted.
Measured: Intraoperative
Longer-Term Albumin-Corrected Serum Calcium
Albumin-corrected total serum calcium concentration measured at postoperative follow-up.
Measured: Postoperative week 8 and postoperative month 6
Longer-Term Intact Parathyroid Hormone
Serum intact parathyroid hormone concentration measured at postoperative follow-up.
Measured: Postoperative week 8 and postoperative month 6
Calcium or Calcitriol Supplementation at Follow-Up
Use of oral calcium and/or calcitriol supplementation at postoperative follow-up.
Measured: Postoperative week 8 and postoperative month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypocalcemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ss. Cyril and Methodius University of Skopje
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Responsible party
- Principal investigator, Prof. Magdalena Bogdanovska Todorovska, Ss. Cyril and Methodius University of Skopje
- Investigators
- Magdalena Bogdanovska Todorovska, MD, PhD, Principal investigator, Ss. Cyril and Methodius University of Skopje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617584
- Sponsor's protocol ID
- 02-2848/10
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with outside researchers. Deidentified aggregate study results may be reported in scientific presentations and publications.
Publications
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.
PubMed 39104194Kim 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.
PubMed 33906431Benmiloud 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.
PubMed 31693081