Clinical Trial

Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging

Recruiting
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Record status
This record was last updated July 15, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
This single-center, prospective, three-phase observational cohort quantifies the relationship between indocyanine green (ICG) fluorescence and early parathyroid function. Adult patients scheduled for unilateral thyroid lobectomy with autotransplantation of the ipsilateral inferior parathyroid gland are enrolled. After intravenous ICG 25 µg/kg, peak fluorescence of the superior parathyroid gland and the common carotid artery (CCA) is recorded at 60-120 seconds to calculate the ratio R = PTG/CCA. Serum parathyroid hormone (PTH) is measured 30 minutes post-operatively. A derivation cohort (\~120 patients) generates R-based thresholds for in-situ preservation versus autotransplantation, which are prospectively validated in an independent cohort (60 patients) together with decision-curve analysis of clinical net benefit.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-01; most recent amendment 2025-07-12.
Status change: Active, Not Recruiting → Recruiting 2025-07-12
Trial Details
NCT Number NCT07010341
Lead Sponsor Fujian Medical University
Conditions Thyroid Surgery
Enrollment 210 participants
Start Date 2025-05-01
Primary Completion 2025-11-30 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-15