NCT07617584Not yet recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Near-Infrared Autofluorescence-Guided Parathyroid Identification During Thyroidectomy
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 21 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jun 2029
- Lead sponsor
- Ss. Cyril and Methodius University of Skopje
- NCT number
- NCT07617584
What you commit to
- Study type: Interventional
- Planned participants: 280
- From 1 Jun 2026 to the primary completion date, 1 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known pre-existing hypoparathyroidism or prior parathyroid surgery.
Other illness
- 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.
Lab values
- Severe chronic kidney disease or end-stage renal disease expected to substantially confound calcium and parathyroid hormone interpretation, as defined by the site investigator.
Other
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Clinic Hospital Coordinator of this site? Confirm its status | Skopje | North Macedonia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.