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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2021

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.

Interventions

  • Procedure: Total thyroidectomy (TT)
    • Standard TT procedure for thyroid carcinoma, for both groups
  • Procedure: Central lymph node dissection (CLND)
    • Standard CLND for thyroid carcinoma, for both groups
  • Diagnostic Test: Sentinel lymph node (SLN) bopsy
    • Intrathyroidal injection of ICG for SL biopsy, for only experimental group
  • Diagnostic Test: Identification of parathyroid glands (PGs)
    • Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group

Arms, Groups and Cohorts

  • Active Comparator: Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy
    • Control group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC) Standard TT+CLND procedure only
  • Experimental: Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
    • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Central lymph node dissetion (CLND)
    • Time Frame: 1 year
    • Number of positive lymph nodes (micrometastases)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 17 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Umraniye Education and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic, A. Prof. of General Surgery and Surgical Oncology – Umraniye Education and Research Hospital
  • Overall Contact(s)
    • Ethem Unal, MD, PhD, USMLE&IFSO-CSS, A. Prof., +90 216 632 1818, drethemunal@gmail.com

Citations Reporting on Results

Zhang X, Shen YP, Li JG, Chen G. Clinical feasibility of imaging with indocyanine green combined with carbon nanoparticles for sentinel lymph node identification in papillary thyroid microcarcinoma. Medicine (Baltimore). 2019 Sep;98(36):e16935. doi: 10.1097/MD.0000000000016935.

Spartalis E, Ntokos G, Georgiou K, Zografos G, Tsourouflis G, Dimitroulis D, Nikiteas NI. Intraoperative Indocyanine Green (ICG) Angiography for the Identification of the Parathyroid Glands: Current Evidence and Future Perspectives. In Vivo. 2020 Jan-Feb;34(1):23-32. doi: 10.21873/invivo.11741. Review.

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