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

NCT07010341 | Recruiting

• 1 other identifier: PT-ICG
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 2

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.

Conditions

Thyroid Surgery

Keywords

Thyroid surgery; Indocyanine Green; Near-Infrared Fluorescence; Parathyroid Perfusion; Perfusion Threshold; Hypocalcemia; Perfusion Ratio

Outcome Measures

Primary Outcomes (3)

• Parathyroid Gland Fluorescence Intensity

  Peak fluorescence intensity of the ipsilateral superior parathyroid gland, captured 60 - 120 seconds after a single intravenous bolus of indocyanine green (25 µg/kg).

  Intra-operative (60 - 120 s post-ICG)

• Common Carotid Artery (CCA) Fluorescence Intensity

  Peak fluorescence intensity of the ipsilateral common carotid artery recorded in the same 60 - 120 second window; serves as the reference signal for perfusion ratio calculations.

  Intra-operative (60 - 120 s post-ICG)

• Parathyroid Hormone (PTH) at 30 Minutes post-surgery

  PTH concentration (pg/mL) measured by chemiluminescent assay 30 minutes after skin closure, reflecting immediate functional status of the preserved superior parathyroid gland.

  30 minutes after surgery

Secondary Outcomes (3)

• Administered ICG Dose

  Intra-operative (time of injection)

• PTH at 6 Hours

  6 hours post-surgery

• PTH at 2 Weeks

  2 weeks post-surgery

Study Arms (2)

Derivation_Cohort

The model-development cohort consisted of 500 consecutive patients drawn from the Thyroid Surgery Department database of Fujian Medical University Union Hospital (Fuzhou, China)

Diagnostic Test: ntra-operative Indocyanine Green (ICG) Fluorescence Quantification

Validation_Cohort

The external validation cohort comprised 300 patients

Diagnostic Test: ntra-operative Indocyanine Green (ICG) Fluorescence Quantification

Interventions

ntra-operative Indocyanine Green (ICG) Fluorescence Quantification DIAGNOSTIC_TEST

After a single intravenous bolus of indocyanine green (25 µg/kg), a near-infrared sensor records raw fluorescence intensity from the superior parathyroid gland and the ipsilateral common carotid artery at 60-120 seconds. No images are stored; only peak intensity values are logged to calculate the perfusion ratio R = PTG / CCA. The measurement is observational, adds ≤2 minutes to operative time, and involves no therapeutic intent.

Derivation_Cohort; Validation_Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive adult patients undergoing unilateral thyroid lobectomy with planned autotransplantation of the ipsilateral inferior parathyroid gland at a single tertiary endocrine-surgery center; recruitment limited to cases in which the superior parathyroid gland can be preserved in situ and evaluated intra-operatively with indocyanine-green fluorescence quantification.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (2)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

NOT YET RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Central Study Contacts

Bo Wang, MD

CONTACT

+13959123550; wangbo@fjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 8, 2025
• Study Start: May 1, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-05

Locations

CN (2)