Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

Study Overview
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Brief Summary
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This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence.

Detailed Description
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Background Thyroid surgery volume continues to increase worldwide over the past few decades. During a total thyroidectomy (TTx), the ultimate goal is to remove all thyroid tissue, whereas damage to adjacent tissue is prevented. However, iatrogenic hypoparathyroidism, as a result of surgical removal or damage to the parathyroid glands, occurs in approximately 30% of the cases. In 2016 near-infrared fluorescence guided surgery with indocyanine green (ICG) was proposed for visualizing viability and blood supply of parathyroid glands during TTx. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins once in the bloodstream, and circulates in the intravascular compartment only. However, one of the limitations of ICG imaging is the subjectivity of the interpretation of fluorescence, which makes the assessment of images inconsistent among studies. There is a clear need for standardization of the evaluation of the perfusion with ICG, since visual evaluation of the fluorescent signal of ICG is not sufficient to reliably predict the perfusion of parathyroid glands. Main research question To develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy including quantitative evaluations of the fluorescent signal. Design This will be a proof-of-concept , prospective cohort study of patients undergoing a total thyroidectomy with ICG-guided fluorescent surgery to evaluate tissue perfusion The main study endpoint is quantification of the fluorescent signal of ICG. Secondary outcomes are data from surgery, postoperative lab values (including calcium, PTH, albumin) and postoperative medication use.

Official Title
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Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

Conditions
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Thyroid Cancer, Thyroid Goiter, Graves Disease

Intervention / Treatment
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* Drug: Indocyanine Green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years Patients undergoing total thyroidectomy as surgical procedure for thyroid cancer, Graves' disease or goiter Patients are eligible for surgery Patients are mentally competent and are able and willing to comply with study procedures Written informed consent Exclusion Criteria: Patients with a known allergy to ICG or iodinated contrast Pregnant or lactating women Patients with previous neck surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indocyanine Green<br> | Drug: Indocyanine Green<br>* ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the fluorescent signal of ICG | Quantification of the fluorescent signal of ICG | At time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of parathyroid gland | Vascularization appearance of parathyroid gland intraoperatively (1= surgeon thinks parathyroid gland is well vascularized, 2 = surgeons thinks parathyroid gland is devascularized) | At time of surgery | 
| Duration of surgery | Duration of surgery in minutes | From start to end of surgery | 
| Postoperative calcium concentration | Postoperative albumin-corrected calcium concentration in blood | Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative) | 
| Postoperative PTH concentration | Postoperative PTH concentration in blood | Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative) | 
| Rate of prescribed postoperative calcium medication | Rate of prescribed postoperative calcium medication | Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative) | 
| Rate of prescribed postoperative vitamin D medication | Rate of prescribed postoperative vitamin D medication | Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid surgery, Indocyanine green (ICG), Hypoparathyroidism