Actively Recruiting
Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging
Led by Fujian Medical University · Updated on 2025-07-15
210
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for unilateral thyroid lobectomy plus central (VI-level) lymph-node dissection.
- Complete identification and in-situ preservation of the ipsilateral superior parathyroid gland during surgery.
- Complete identification and autotransplantation of the ipsilateral inferior parathyroid gland during surgery.
- Serum 25-hydroxy-vitamin D level of 30 ng/mL or higher at baseline, or after supplementation with confirmed re-test.
- Surgery and all postoperative follow-up performed at the study center.
- Able and willing to provide written informed consent.
You will not qualify if you...
- Prior surgery on the thyroid or parathyroid glands.
- Severe liver or kidney impairment, or other serious metabolic bone disease.
- Pregnancy or breastfeeding.
- Known allergy to indocyanine green or iodine-containing compounds.
- Unable or unwilling to comply with postoperative visits and blood tests.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
2
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
B
Bo Wang, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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