Quantitative intra-operative parathyroid perfusion measurement using indocyanine green fluorescence
Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging: A Prospective Observational Study
This project tests whether measuring ICG fluorescence during unilateral thyroid lobectomy can predict early parathyroid hormone levels and help decide if the superior parathyroid gland can stay in place or should be autotransplanted.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Sex | All |
| Sponsor | Fujian Medical University Academic / other |
| Locations | 2 sites (Fuzhou, Fujian and 1 other locations) |
| Trial ID | NCT07010341 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults scheduled for unilateral thyroid lobectomy with planned autotransplantation of the ipsilateral inferior parathyroid gland, able to have surgery and follow‑up at the study center, and with baseline 25‑hydroxyvitamin D ≥30 ng/mL are ideal candidates.
Not a fit: Patients with prior thyroid or parathyroid surgery, severe hepatic or renal impairment, pregnancy or lactation, known allergy to ICG/iodine, or inability to complete follow‑up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could give surgeons an objective intra-operative threshold to reduce early postoperative hypocalcemia and unnecessary autotransplantation.
How similar studies have performed: Prior small feasibility and observational studies have shown ICG fluorescence can visualize parathyroid perfusion, but reproducible quantitative thresholds to guide intra-operative decisions remain largely unvalidated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Fuzhou, Fujian and 1 other locations
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Bo Wang, MD
- Email: wangbo@fjmu.edu.cn
- Phone: +13959123550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.