Near-infrared Fluorescence With Indocyanine Green for Identification of Sentinels and Parathyroids During Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
Indocyanine green (ICG) is a water-soluble organic dye that is cleared totally through the hepatobiliary system. It has a half-life of 3-4 mins, which allows repeated applications. Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) imaging has been recently introduced, and has been suggested as a useful tool for the identification and preservation of the parathyroid glands (PGs) during total thyroidectomy (TT). ICG can also be used for sentinel lymph node (SLN) biopsy to predict the micrometastases in central lymph nodes (CLN) in thyroid carcinoma, and central lymph node dissection can reduce local recurrence.

Detailed Description
-----------------
Incidence of thyroid cancer has doubled between 1980 and 2020, and it is now the fifth most common malignant tumor among women. The majority are papillary thyroid cancer (PTC), and TT is the procedure of choice. Since the micrometastasis rate of the central lymph nodes (CLNs) is about 30% to 90% in PTC, CLN dissection can improve the prognosis and reduce tumor recurrence as well as provide accurate information for the evaluation of tumor staging. However, TT procedure has some important complications such as vocal cord paralysis (VCP) and hypocalcemia (due to accicental parathyroidectomy or damage to the parathyroid gland-PG- vasculature). Use of intraoperative nerve monitoring (IONM) has reduced the rate of VCP. However, the incidence of postoperative hypocalcemia is still high (15-70%), and it is now the most common complication of TT. Intraoperative identification of SLNs and PGs can help surgeon to overcome these problems.

Official Title
-----------------
Near-infrared (NIR) Fluorescence Imaging With Indocyanine Green (ICG) for Identification of Sentinel Lymph Nodes and Parathyroid Glands During Total Thyroidectomy: Prospective Randomized Clinical Trial

Conditions
-----------------
Thyroid Cancer, Thyroid Carcinoma, Papillary, Thyroid Metastases, Thyroid Neoplasms, Sentinel Lymph Node, Lymph Node Metastases

Intervention / Treatment
-----------------
* Procedure: Total thyroidectomy (TT)
* Procedure: Central lymph node dissection (CLND)
* Diagnostic Test: Sentinel lymph node (SLN) bopsy
* Diagnostic Test: Identification of parathyroid glands (PGs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy procedure Patients at or over 17 years Exclusion Criteria: Previous thyroid surgery Patients below 17 years

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy<br>Control group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC) Standard TT+CLND procedure only | Procedure: Total thyroidectomy (TT)<br>* Standard TT procedure for thyroid carcinoma, for both groups<br>Procedure: Central lymph node dissection (CLND)<br>* Standard CLND for thyroid carcinoma, for both groups<br>|
| Experimental: Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node<br>Experimental group- Sentinel lymph node dissection (SLND) after intratumoral indocyanine green (ICG) injection and visualization of all 4 parathyroid glands with infra-red (NIR) fluorescence after intravenous (iv) ICG injection, during total thyroidectomy and central lymph node dissection (CLND). TT+CLND with NIR fluorescence ICG | Procedure: Total thyroidectomy (TT)<br>* Standard TT procedure for thyroid carcinoma, for both groups<br>Procedure: Central lymph node dissection (CLND)<br>* Standard CLND for thyroid carcinoma, for both groups<br>Diagnostic Test: Sentinel lymph node (SLN) bopsy<br>* Intrathyroidal injection of ICG for SL biopsy, for only experimental group<br>Diagnostic Test: Identification of parathyroid glands (PGs)<br>* Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion | Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy | 1 year | 
| Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast | İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central lymph node dissetion (CLND) | Number of positive lymph nodes (micrometastases) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near-infrared (NIR) fluorescence, Total thyroidectomy, Parathyroid glands, Indocyanine green (ICG), Central lymph node dissection