NCT07010341 Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging
| NCT ID | NCT07010341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fujian Medical University |
| Condition | Thyroid Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 210 participants in total. It began in 2025-05-01 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07010341 clinical trial?
This trial is open to participants of all sexes, studying Thyroid Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07010341 currently recruiting?
Yes, NCT07010341 is actively recruiting participants. Contact the research team at wangbo@fjmu.edu.cn for enrollment information.
Where is the NCT07010341 trial being conducted?
This trial is being conducted at Fuzhou, China, Fuzhou, China.
Who is sponsoring the NCT07010341 clinical trial?
NCT07010341 is sponsored by Fujian Medical University. The trial plans to enroll 210 participants.