RecruitingNCT07010341

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

Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging: A Prospective Observational Study

Sponsor

Fujian Medical University

Enrollment

210 participants

Start Date

May 1, 2025

Study Type

OBSERVATIONAL

Conditions

Thyroid surgery

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.

Eligibility

Inclusion Criteria7

Scheduled for unilateral thyroid lobectomy plus central (VI-level) lymph-node dissection.
Intra-operative findings consistent with:
Complete identification and in-situ preservation of the ipsilateral superior parathyroid gland;
Complete identification and autotransplantation of the ipsilateral inferior parathyroid gland.
Serum 25-hydroxy-vitamin D ≥ 30 ng/mL at baseline; patients below this level may be enrolled after standardized vitamin-D and calcium supplementation with re-test confirming ≥ 30 ng/mL.
Surgery and all postoperative follow-up performed at the study center.
Able and willing to provide written informed consent.

Exclusion Criteria5

Prior surgery on the thyroid or parathyroid glands.
Severe hepatic or renal impairment, or other serious metabolic bone disease.
Pregnancy or lactation.
Known hypersensitivity to indocyanine green or iodine-containing compounds.
Inability or unwillingness to comply with postoperative visits and blood testing.

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Interventions

DIAGNOSTIC_TESTntra-operative Indocyanine Green (ICG) Fluorescence Quantification

After a single intravenous bolus of indocyanine green (25 µg/kg), a near-infrared sensor records raw fluorescence intensity from the superior parathyroid gland and the ipsilateral common carotid artery at 60-120 seconds. No images are stored; only peak intensity values are logged to calculate the perfusion ratio R = PTG / CCA. The measurement is observational, adds ≤2 minutes to operative time, and involves no therapeutic intent.