Quantitative intra-operative parathyroid perfusion measurement using indocyanine green fluorescence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, prospective, three-phase observational cohort uses intra-operative near-infrared imaging with indocyanine green (ICG) to quantify parathyroid perfusion during unilateral thyroid lobectomy. After a standardized ICG dose (25 µg/kg) the peak fluorescence of the superior parathyroid gland and the common carotid artery is measured at 60–120 seconds to calculate an R ratio (PTG/CCA). A pilot phase optimizes acquisition parameters, a derivation cohort (~120 patients) models the relationship between R and 30-minute postoperative PTH to generate R_low and R_high thresholds, and a validation cohort (~60 patients) prospectively tests these thresholds against surgeon judgment. Predictive performance (AUC, sensitivity, specificity) and net clinical benefit are evaluated with decision-curve analysis to determine whether an R-based rule can reduce early post-thyroidectomy hypocalcemia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Not yet recruiting

Study contacts

• Study coordinator: Bo Wang, MD
• Email: wangbo@fjmu.edu.cn
• Phone: +13959123550

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.