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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFujian Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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 ≥ 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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Derivation_Cohort1 intervention
Group B: Validation_Cohort1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Intra-operative (60 - 120 s post-ICG)
2

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.

Time frame
Intra-operative (60 - 120 s post-ICG)
3

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.

Time frame
30 minutes after surgery

Secondary outcomes

1

Administered ICG Dose

Total dose of indocyanine green (µg/kg) delivered during the procedure.

Time frame
Intra-operative (time of injection)
2

PTH at 6 Hours

PTH concentration measured 6 hours after surgery.

Time frame
6 hours post-surgery
3

PTH at 2 Weeks

PTH concentration measured 14 ± 2 days after surgery.

Time frame
2 weeks post-surgery

Other outcomes

Sponsors and contacts

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