Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fl… (NCT07010341) | Clinical Trial Compass
RecruitingNot Applicable
Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging
China210 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parathyroid Gland Fluorescence Intensity
Timeframe: Intra-operative (60 - 120 s post-ICG)
2
Common Carotid Artery (CCA) Fluorescence Intensity
Timeframe: Intra-operative (60 - 120 s post-ICG)
3
Parathyroid Hormone (PTH) at 30 Minutes post-surgery