<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04424485</url>
  </required_header>
  <id_info>
    <org_study_id>B.10.1.TKH.4.34.H.GP.0.01/213</org_study_id>
    <nct_id>NCT04424485</nct_id>
  </id_info>
  <brief_title>Near-infrared Fluorescence With Indocyanine Green for Identification of Sentinels and Parathyroids During Thyroidectomy</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Indocyanine green (ICG) is a water-soluble organic dye that is cleared totally through the&#xD;
      hepatobiliary system. It has a half-life of 3-4 mins, which allows repeated applications.&#xD;
      Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) imaging has been&#xD;
      recently introduced, and has been suggested as a useful tool for the identification and&#xD;
      preservation of the parathyroid glands (PGs) during total thyroidectomy (TT). ICG can also be&#xD;
      used for sentinel lymph node (SLN) biopsy to predict the micrometastases in central lymph&#xD;
      nodes (CLN) in thyroid carcinoma, and central lymph node dissection can reduce local&#xD;
      recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Incidence of thyroid cancer has doubled between 1980 and 2020, and it is now the fifth most&#xD;
      common malignant tumor among women. The majority are papillary thyroid cancer (PTC), and TT&#xD;
      is the procedure of choice. Since the micrometastasis rate of the central lymph nodes (CLNs)&#xD;
      is about 30% to 90% in PTC, CLN dissection can improve the prognosis and reduce tumor&#xD;
      recurrence as well as provide accurate information for the evaluation of tumor staging.&#xD;
      However, TT procedure has some important complications such as vocal cord paralysis (VCP) and&#xD;
      hypocalcemia (due to accicental parathyroidectomy or damage to the parathyroid gland-PG-&#xD;
      vasculature). Use of intraoperative nerve monitoring (IONM) has reduced the rate of VCP.&#xD;
      However, the incidence of postoperative hypocalcemia is still high (15-70%), and it is now&#xD;
      the most common complication of TT. Intraoperative identification of SLNs and PGs can help&#xD;
      surgeon to overcome these problems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion</measure>
    <time_frame>1 year</time_frame>
    <description>Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast</measure>
    <time_frame>1 year</time_frame>
    <description>İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Central lymph node dissetion (CLND)</measure>
    <time_frame>1 year</time_frame>
    <description>Number of positive lymph nodes (micrometastases)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Thyroid Cancer</condition>
  <condition>Thyroid Carcinoma, Papillary</condition>
  <condition>Thyroid Metastases</condition>
  <condition>Thyroid Neoplasms</condition>
  <condition>Sentinel Lymph Node</condition>
  <condition>Lymph Node Metastases</condition>
  <arm_group>
    <arm_group_label>Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC)&#xD;
Standard TT+CLND procedure only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).&#xD;
TT+CLND with NIR fluorescence ICG</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total thyroidectomy (TT)</intervention_name>
    <description>Standard TT procedure for thyroid carcinoma, for both groups</description>
    <arm_group_label>Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node</arm_group_label>
    <arm_group_label>Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Central lymph node dissection (CLND)</intervention_name>
    <description>Standard CLND for thyroid carcinoma, for both groups</description>
    <arm_group_label>Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node</arm_group_label>
    <arm_group_label>Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sentinel lymph node (SLN) bopsy</intervention_name>
    <description>Intrathyroidal injection of ICG for SL biopsy, for only experimental group</description>
    <arm_group_label>Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Identification of parathyroid glands (PGs)</intervention_name>
    <description>Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group</description>
    <arm_group_label>Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy&#xD;
             procedure&#xD;
&#xD;
          -  Patients at or over 17 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous thyroid surgery&#xD;
&#xD;
          -  Patients below 17 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ethem Unal, MD, PhD, USMLE&amp;IFSO-CSS, A. Prof.</last_name>
    <phone>+90 216 632 1818</phone>
    <phone_ext>1950</phone_ext>
    <email>drethemunal@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sema Yuksekdag, MD</last_name>
    <phone>+90 216 632 1818</phone>
    <phone_ext>1950</phone_ext>
    <email>drsemayuksekdag@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Umraniye Education and Research Hospital, Department of General Surgery</name>
      <address>
        <city>Istanbul</city>
        <zip>34760</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ethem Unal, MD, PhD, A. Prof. of Surgery &amp; Surgical Oncology</last_name>
      <phone>+90 216 632 1818</phone>
      <phone_ext>1950</phone_ext>
      <email>drethemunal@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sema Yuksekdag, MD</last_name>
      <phone>+90 216 632 1818</phone>
      <phone_ext>1950</phone_ext>
      <email>drsemayuksekdag@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://scholar.google.com.tr/citations?user=6bFlCZwAAAAJ&amp;hl=tr</url>
    <description>Ethem Unal</description>
  </link>
  <results_reference>
    <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.</citation>
    <PMID>31490376</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>31882459</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ethem Unal, M.D., PhD, Associate Prof of Surgery &amp; Surgic</investigator_full_name>
    <investigator_title>A. Prof. of General Surgery and Surgical Oncology</investigator_title>
  </responsible_party>
  <keyword>Near-infrared (NIR) fluorescence</keyword>
  <keyword>Total thyroidectomy</keyword>
  <keyword>Parathyroid glands</keyword>
  <keyword>Indocyanine green (ICG)</keyword>
  <keyword>Central lymph node dissection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Lymphatic Metastasis</mesh_term>
    <mesh_term>Carcinoma, Papillary</mesh_term>
    <mesh_term>Thyroid Cancer, Papillary</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parathyroid Hormone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Excel data is available upon request at drethemunal@gmail.com</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>1 year</ipd_time_frame>
    <ipd_access_criteria>Please request study protocol and data (when available) at drethemunal@gmail.com</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04424485
org study id: B.10.1.TKH.4.34.H.GP.0.01/213
nct id: NCT04424485
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion
time frame: 1 year
description: Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy
measure: Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast
time frame: 1 year
description: İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)
measure: Central lymph node dissetion (CLND)
time frame: 1 year
description: Number of positive lymph nodes (micrometastases)
arm group label: Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy
arm group type: Active Comparator
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 group label: Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
arm group type: Experimental
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: Total thyroidectomy (TT)
description: Standard TT procedure for thyroid carcinoma, for both groups
arm group label: Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
arm group label: Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy
intervention type: Procedure
intervention name: Central lymph node dissection (CLND)
description: Standard CLND for thyroid carcinoma, for both groups
arm group label: Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
arm group label: Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy
intervention type: Diagnostic Test
intervention name: Sentinel lymph node (SLN) bopsy
description: Intrathyroidal injection of ICG for SL biopsy, for only experimental group
arm group label: Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
intervention type: Diagnostic Test
intervention name: Identification of parathyroid glands (PGs)
description: Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group
arm group label: Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
criteria: 
gender: All
minimum age: 17 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ethem Unal, MD, PhD, USMLE&IFSO-CSS, A. Prof.
phone: +90 216 632 1818
phone ext: 1950
email: drethemunal@gmail.com
last name: Sema Yuksekdag, MD
phone: +90 216 632 1818
phone ext: 1950
email: drsemayuksekdag@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
url: https://scholar.google.com.tr/citations?user=6bFlCZwAAAAJ&hl=tr
description: Ethem Unal
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.
PMID: 31490376
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.
PMID: 31882459
responsible party type: Principal Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
investigator title: A. Prof. of General Surgery and Surgical Oncology
mesh term: Neoplasm Metastasis
mesh term: Thyroid Neoplasms
mesh term: Lymphatic Metastasis
mesh term: Carcinoma, Papillary
mesh term: Thyroid Cancer, Papillary
mesh term: Thyroid Diseases
mesh term: Parathyroid Hormone
sharing ipd: Yes
ipd description: Excel data is available upon request at drethemunal@gmail.com
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 1 year
ipd access criteria: Please request study protocol and data (when available) at drethemunal@gmail.com