Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging

Launched by FUJIAN MEDICAL UNIVERSITY · Jun 1, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a special imaging technique called indocyanine green (ICG) fluorescence to help doctors assess the health of parathyroid glands during thyroid surgery. The study focuses on patients who are about to have surgery to remove one lobe of the thyroid gland and may need to move (or transplant) the parathyroid gland to ensure it continues to function. By using ICG, doctors can measure how well blood is flowing to these glands, which is important for their health. After the surgery, blood tests will be done to check the levels of parathyroid hormone, helping to determine if the glands are functioning properly.

To be eligible for this trial, patients must be scheduled for a specific type of thyroid surgery and should have certain health conditions, like a sufficient level of vitamin D. They should also be able to provide consent to participate in the study. Participants can expect to undergo routine surgery with some additional monitoring related to the ICG imaging and follow-up blood tests. It's important to note that individuals with a history of thyroid or parathyroid surgery, certain health issues, or who are pregnant or breastfeeding cannot take part in this study.

Gender

ALL

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.