Actively Recruiting
Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging: A Prospective Observational Study
Led by Fujian Medical University · Updated on 2025-07-15
210
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults undergoing unilateral thyroid lobectomy with planned autotransplantation of the ipsilateral inferior parathyroid gland to better understand parathyroid gland function after surgery. The study aims to quantify the relationship between indocyanine green (ICG) fluorescence imaging and early parathyroid function, addressing the challenge of accurately assessing parathyroid perfusion to reduce post-thyroidectomy hypocalcemia. This prospective observational study includes a pilot phase, a derivation phase of about 120 patients, and a validation phase of 60 patients to develop and test quantitative fluorescence thresholds for surgical decision-making. During surgery, participants receive a single intravenous dose of ICG at 25 µg/kg. A near-infrared sensor measures the fluorescence intensity of the superior parathyroid gland and the ipsilateral common carotid artery between 60 and 120 seconds after injection to calculate a perfusion ratio. This observational measurement adds less than two minutes to the operation and does not involve treatment. The study includes both a derivation cohort to establish thresholds and a validation cohort to prospectively assess surgeon decisions, hormone levels, and hypocalcemia incidence. Participants are involved through surgery at the study center with follow-up blood tests measuring parathyroid hormone levels at 30 minutes, 6 hours, and 2 weeks post-operation. Data collection includes fluorescence intensity values and hormone measurements to analyze the relationship between perfusion and parathyroid function. The study also monitors safety related to ICG use and records adverse events. Overall participation includes surgery and postoperative follow-up visits to evaluate the accuracy and clinical utility of ICG fluorescence imaging in thyroid surgery.
CONDITIONS
Brief 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
- Complete identification and autotransplantation of the ipsilateral inferior parathyroid gland
- Serum 25-hydroxy-vitamin D 2 30 ng/mL at baseline or after supplementation with re-test confirming 2 30 ng/mL
- 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 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants undergo a single intra-operative assessment where a fluorescent dye (indocyanine green) is injected and near-infrared sensors measure parathyroid gland perfusion during thyroid surgery.
1 visit (in-person, during surgery)
Duration - Up to 2 weeks post-surgery
Participants have blood tests to monitor parathyroid hormone levels and calcium metabolism after surgery.
Visits at 30 minutes, 6 hours, and 2 weeks post-surgery
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
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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