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

Primary Purpose

Thyroid Cancer, Thyroid Carcinoma, Papillary, Thyroid Metastases

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Total thyroidectomy (TT)
Central lymph node dissection (CLND)
Sentinel lymph node (SLN) bopsy
Identification of parathyroid glands (PGs)
Sponsored by
Umraniye Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Cancer focused on measuring Near-infrared (NIR) fluorescence, Total thyroidectomy, Parathyroid glands, Indocyanine green (ICG), Central lymph node dissection

Eligibility Criteria

17 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Umraniye Education and Research Hospital, Department of General SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy

Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node

Arm Description

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 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

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

Central lymph node dissetion (CLND)
Number of positive lymph nodes (micrometastases)

Full Information

First Posted
June 2, 2020
Last Updated
June 5, 2020
Sponsor
Umraniye Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04424485
Brief Title
Near-infrared Fluorescence With Indocyanine Green for Identification of Sentinels and Parathyroids During Thyroidectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umraniye Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Thyroid Carcinoma, Papillary, Thyroid Metastases, Thyroid Neoplasms, Sentinel Lymph Node, Lymph Node Metastases
Keywords
Near-infrared (NIR) fluorescence, Total thyroidectomy, Parathyroid glands, Indocyanine green (ICG), Central lymph node dissection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy
Arm Type
Active Comparator
Arm Description
Control group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC) Standard TT+CLND procedure only
Arm Title
Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Total thyroidectomy (TT)
Intervention Description
Standard TT procedure for thyroid carcinoma, for both groups
Intervention Type
Procedure
Intervention Name(s)
Central lymph node dissection (CLND)
Intervention Description
Standard CLND for thyroid carcinoma, for both groups
Intervention Type
Diagnostic Test
Intervention Name(s)
Sentinel lymph node (SLN) bopsy
Intervention Description
Intrathyroidal injection of ICG for SL biopsy, for only experimental group
Intervention Type
Diagnostic Test
Intervention Name(s)
Identification of parathyroid glands (PGs)
Intervention Description
Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group
Primary Outcome Measure Information:
Title
Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion
Description
Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy
Time Frame
1 year
Title
Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast
Description
İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Central lymph node dissetion (CLND)
Description
Number of positive lymph nodes (micrometastases)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ethem Unal, MD, PhD, USMLE&IFSO-CSS, A. Prof.
Phone
+90 216 632 1818
Ext
1950
Email
drethemunal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sema Yuksekdag, MD
Phone
+90 216 632 1818
Ext
1950
Email
drsemayuksekdag@gmail.com
Facility Information:
Facility Name
Umraniye Education and Research Hospital, Department of General Surgery
City
Istanbul
ZIP/Postal Code
34760
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethem Unal, MD, PhD, A. Prof. of Surgery & Surgical Oncology
Phone
+90 216 632 1818
Ext
1950
Email
drethemunal@gmail.com
First Name & Middle Initial & Last Name & Degree
Sema Yuksekdag, MD
Phone
+90 216 632 1818
Ext
1950
Email
drsemayuksekdag@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Excel data is available upon request at drethemunal@gmail.com
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
Please request study protocol and data (when available) at drethemunal@gmail.com
Citations:
PubMed Identifier
31490376
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: 10.1097/MD.0000000000016935.
Results Reference
result
PubMed Identifier
31882459
Citation
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.
Results Reference
result
Links:
URL
https://scholar.google.com.tr/citations?user=6bFlCZwAAAAJ&hl=tr
Description
Ethem Unal

Learn more about this trial

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

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