Near-infrared Fluorescence With Indocyanine Green for Identification of Sentinels and Parathyroids During Thyroidectomy
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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 2, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJune 11, 2020
June 1, 2020
1 year
June 2, 2020
June 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Central lymph node dissetion (CLND)
1 year
Study Arms (2)
Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy
ACTIVE COMPARATORControl group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC) Standard TT+CLND procedure only
Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
EXPERIMENTALExperimental 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
Interventions
Standard TT procedure for thyroid carcinoma, for both groups
Standard CLND for thyroid carcinoma, for both groups
Intrathyroidal injection of ICG for SL biopsy, for only experimental group
Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group
Eligibility Criteria
You may qualify if:
- Thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy procedure
- Patients at or over 17 years
You may not qualify if:
- Previous thyroid surgery
- Patients below 17 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Umraniye Education and Research Hospital, Department of General Surgery
Istanbul, 34760, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 31490376RESULTSpartalis 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.
PMID: 31882459RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- A. Prof. of General Surgery and Surgical Oncology
Study Record Dates
First Submitted
June 2, 2020
First Posted
June 11, 2020
Study Start
June 1, 2020
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
June 11, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 1 year
- Access Criteria
- Please request study protocol and data (when available) at drethemunal@gmail.com
Excel data is available upon request at drethemunal@gmail.com