Thyroid SurgeryNCT07010341
Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging
An observational study of Thyroid Surgery, run by Fujian Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Surgery
- What is being tested?
- ntra-operative Indocyanine Green (ICG) Fluorescence Quantification
- Type of treatment
- Injection or infusion
- How many people
- 210 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2025to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Bo Wang, MD, +13959123550, wangbo@fjmu.edu.cn
Bo Wang MD, Principal Investigator
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Bo Wang, MD, +86 13959123550, wangbo@fjmu.edu.cn
About this study
Official title: Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging: A Prospective Observational Study
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.
Read the detailed description
Post-thyroidectomy hypocalcemia, reported in 5-30 % of cases, is largely attributable to inaccurate assessment of parathyroid perfusion. Conventional intra-operative judgment-based on gland color, capillary bleeding and pulsation-is subjective and non-quantitative. Near-infrared fluorescence imaging with indocyanine green (ICG) allows real-time visualization of tissue perfusion, yet no widely accepted quantitative threshold exists to guide in-situ preservation versus autotransplantation of parathyroid glands.
The PT-ICG study addresses this gap through:
Target population: Patients undergoing unilateral thyroid lobectomy with planned autotransplantation of the ipsilateral inferior parathyroid gland, isolating evaluation to the superior gland.
Pilot phase (n=30): Optimization confirmed an ICG dose of 25 µg/kg and a 60-120 s acquisition window, with the common carotid artery (CCA) providing a stable reference; well-perfused glands exhibited R values ~0.8-3.0.
Derivation phase (n≈120): The relationship between R and 30-min postoperative PTH is modeled; ROC analysis and the Youden index yield R_low and R_high thresholds, internally validated with bootstrap resampling.
Validation phase (n=60): Prospective application of thresholds documents surgeon decisions, postoperative PTH, and hypocalcemia incidence; predictive performance (AUC, sensitivity, specificity) and net clinical benefit (decision-curve analysis) of the R-based strategy are compared with standard clinical judgment.
Sample size and statistics: With an anticipated correlation r≈0.45, α=0.05 (two-sided) and 90 % power, ≥110 patients are required; allowing 10 % attrition, 120-130 will be enrolled.
Data management and safety: REDCap will support double data entry and monitoring; ICG-related adverse events will be recorded; the study adheres to GCP and the Declaration of Helsinki and has received ethics committee approval.
By establishing actionable ICG fluorescence thresholds and a decision algorithm, the study seeks to provide a quantitative tool for real-time intra-operative perfusion assessment, potentially reducing hypocalcemia and informing future multicenter trials.
full SAP available upon request / will be posted as separate document.
- Conditions
- Thyroid Surgery
- Being tested
- ntra-operative Indocyanine Green (ICG) Fluorescence Quantification
- Keywords
- Thyroid surgery, Indocyanine Green, Near-Infrared Fluorescence, Parathyroid Perfusion, Perfusion Threshold, Hypocalcemia, Perfusion Ratio
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ntra-operative Indocyanine Green (ICG) Fluorescence QuantificationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: ntra-operative Indocyanine Green (ICG) Fluorescence Quantification | |
| Validation_Cohort | The external validation cohort comprised 300 patients Receives: Diagnostic Test: ntra-operative Indocyanine Green (ICG) Fluorescence Quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 30 minutes after surgery
Secondary outcomes (3)
Administered ICG Dose
Total dose of indocyanine green (µg/kg) delivered during the procedure.
Measured: Intra-operative (time of injection)
PTH at 6 Hours
PTH concentration measured 6 hours after surgery.
Measured: 6 hours post-surgery
PTH at 2 Weeks
PTH concentration measured 14 ± 2 days after surgery.
Measured: 2 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 May 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid SurgeryStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010341
- Sponsor's protocol ID
- PT-ICG
- Status last verified
- May 2025
- First submitted
- 25 May 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07010341
- Acronym / sponsor ID
- PT-ICG
- Conditions
- Thyroid Surgery
- Keywords
- Thyroid surgery, Indocyanine Green, Near-Infrared Fluorescence, Parathyroid Perfusion, Perfusion Threshold, Hypocalcemia, Perfusion Ratio
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-thyroidectomy hypocalcemia, reported in 5-30 % of cases, is largely attributable to inaccurate assessment of parathyroid perfusion. Conventional intra-operative judgment-based on gland color, capillary bleeding and pulsation-is subjective and non-quantitative. Near-infrared fluorescence imaging with indocyanine green (ICG) allows real-time visualization of tissue perfusion, yet no widely accepted quantitative threshold exists to guide in-situ preservation versus autotransplantation of parathyroid glands.
The PT-ICG study addresses this gap through:
Target population: Patients undergoing unilateral thyroid lobectomy with planned autotransplantation of the ipsilateral inferior parathyroid gland, isolating evaluation to the superior gland.
Pilot phase (n=30): Optimization confirmed an ICG dose of 25 µg/kg and a 60-120 s acquisition window, with the common carotid artery (CCA) providing a stable reference; well-perfused glands exhibited R values ~0.8-3.0.
Derivation phase (n≈120): The relationship between R and 30-min postoperative PTH is modeled; ROC analysis and the Youden index yield R_low and R_high thresholds, internally validated with bootstrap resampling.
Validation phase (n=60): Prospective application of thresholds documents surgeon decisions, postoperative PTH, and hypocalcemia incidence; predictive performance (AUC, sensitivity, specificity) and net clinical benefit (decision-curve analysis) of the R-based strategy are compared with standard clinical judgment.
Sample size and statistics: With an anticipated correlation r≈0.45, α=0.05 (two-sided) and 90 % power, ≥110 patients are required; allowing 10 % attrition, 120-130 will be enrolled.
Data management and safety: REDCap will support double data entry and monitoring; ICG-related adverse events will be recorded; the study adheres to GCP and the Declaration of Helsinki and has received ethics committee approval.
By establishing actionable ICG fluorescence thresholds and a decision algorithm, the study seeks to provide a quantitative tool for real-time intra-operative perfusion assessment, potentially reducing hypocalcemia and informing future multicenter trials.
full SAP available upon request / will be posted as separate document.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation_Cohort | – | Diagnostic Test: ntra-operative Indocyanine Green (ICG) Fluorescence QuantificationThe model-development cohort consisted of 500 consecutive patients drawn from the Thyroid Surgery Department database of Fujian Medical University Union Hospital (Fuzhou, China) |
| Validation_Cohort | – | Diagnostic Test: ntra-operative Indocyanine Green (ICG) Fluorescence QuantificationThe external validation cohort comprised 300 patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ntra-operative Indocyanine Green (ICG) Fluorescence QuantificationAfter 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. | Diagnostic test | Derivation_Cohort, Validation_Cohort |
Primary outcome
Parathyroid Gland Fluorescence Intensity
Time frame: Intra-operative (60 - 120 s post-ICG)
Peak fluorescence intensity of the ipsilateral superior parathyroid gland, captured 60 - 120 seconds after a single intravenous bolus of indocyanine green (25 µg/kg).
Common Carotid Artery (CCA) Fluorescence Intensity
Time frame: Intra-operative (60 - 120 s post-ICG)
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.
Parathyroid Hormone (PTH) at 30 Minutes post-surgery
Time frame: 30 minutes after surgery
PTH concentration (pg/mL) measured by chemiluminescent assay 30 minutes after skin closure, reflecting immediate functional status of the preserved superior parathyroid gland.
3 secondary outcomes
Administered ICG Dose
Time frame: Intra-operative (time of injection)
PTH at 6 Hours
Time frame: 6 hours post-surgery
PTH at 2 Weeks
Time frame: 2 weeks post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Surgery, run by Fujian Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Wang, MD (+13959123550, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parathyroid Gland Fluorescence Intensity (time frame: Intra-operative (60 - 120 s post-ICG)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.