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

Thyroid Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04424485
• Other study ID #: B.10.1.TKH.4.34.H.GP.0.01/213
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2020
• Source: Umraniye Education and Research Hospital
• Contact: Ethem Unal, MD, PhD, USMLE&IFSO-CSS, A. Prof.
• Phone: +90 216 632 1818
• Email: drethemunal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymph Node Metastases
• Neoplasm Metastasis
• Sentinel Lymph Node
• Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Carcinoma, Papillary
• Thyroid Diseases
• Thyroid Metastases
• Thyroid Neoplasms

Intervention

Procedure:
• Total thyroidectomy (TT)
Standard TT procedure for thyroid carcinoma, for both groups
• 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
• Identification of parathyroid glands (PGs)
Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group

Locations

Country	Name	City	State
Turkey	Umraniye Education and Research Hospital, Department of General Surgery	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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; — View Citation

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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast	Intravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)	1 year
Secondary	Central lymph node dissetion (CLND)	Number of positive lymph nodes (micrometastases)	1 year

External Links

•   Ethem Unal