xml: <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/NCT06028282</url>
    </required_header>
    <id_info>
      <org_study_id>SUNYUMU 1642552</org_study_id>
      <nct_id>NCT06028282</nct_id>
    </id_info>
    <brief_title>Post-RAI Therapy Dosimetry and Quality Assessment of Target Tissue Dosing</brief_title>
    <acronym>Varian</acronym>
    <official_title>Post-RAI Therapy Dosimetry and Quality Assessment of Target Tissue Dosing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>State University of New York - Upstate Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>State University of New York - Upstate Medical University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial study is to(1) determine the tissue specific dose of I-131&#xD;
        taken up by residing thyroid issue in the thyroid bed post-RAI along with any other sites in&#xD;
        the neck and mediastinum as well as (2) correlate the dose delivered to residual tissues in&#xD;
        the neck with patient follow-up based clinical outcomes, biochemical and imaging data&#xD;
        following RAI therapy in patients with well-differentiated thyroid cancer (DTC). The main&#xD;
        question[s] it aims to answer are:&#xD;
  &#xD;
          -  [question 1] How can obtained whole body and planar images more adequately depict&#xD;
             residual iodine-avid disease in the thyroid bed, neck or mediastinum?&#xD;
  &#xD;
          -  [question 2] How can we obtain information on the dose taken up by the tumor remnant to&#xD;
             know how much radionuclide actually went to the residual disease/tissue? Participants&#xD;
             will [describe the main tasks participants will be asked to do, treatments they'll be&#xD;
             given and use bullets if it is more than 2 items].&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In our current clinical practice, patients with well-differentiated thyroid cancer (DTC) who&#xD;
        receive oral administration of radioiodine 1-131 (RAI) have whole body and planar images&#xD;
        obtained 4-5 days post-treatment. These images often do not adequately depict residual&#xD;
        iodine-avid disease in the thyroid bed, neck or mediastinum. Further, no information about&#xD;
        what dose taken up by the tumor remnant is obtained and thus we are unable to know how much&#xD;
        radionuclide actually went to the residual disease/tissue.&#xD;
  &#xD;
        Using single photon emission computed tomography (SPECT)/CT we will be able to better&#xD;
        localize and evaluate disease/tissue remnant or distant iodine-avid metastatic disease. In&#xD;
        addition, using Varian Velocity Theranostics Dosimetry suite of software applications, we&#xD;
        will be able to do dosimetry on post-RAI therapy patients and be able to better correlate&#xD;
        clinical outcomes with tumor absorbed dose in addition to provide quality improvement for the&#xD;
        radioiodine ablation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">November 8, 2021</start_date>
    <completion_date type="Anticipated">June 8, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 8, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Staging Accuracy and Improved Clinical Patient Care</measure>
      <time_frame>24 months</time_frame>
      <description>In addition to providing a thorough evaluation for any iodine-avid disease in the thyroid bed, neck soft tissues and mediastinum, a SPECT/CT with a high-energy collimator will help better assess the clinical stage of disease at the time of RAI treatment. Thus, better staging accuracy will be obtained and this will improve clinical patient management</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Thyroid Disease</condition>
    <arm_group>
      <arm_group_label>Radioiodine I-131 (RAI)</arm_group_label>
      <description>oral administration of radioiodine I-131 (RAI) to patients with well-differentiated thyroid cancer</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>SPECT</intervention_name>
      <description>SPECT of thyroid traced with I-131</description>
      <arm_group_label>Radioiodine I-131 (RAI)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Thyroid Disease&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All minorities&#xD;
  &#xD;
            -  18 years of age and older&#xD;
  &#xD;
            -  Ability to give consent&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  Differentiated thyroid cancer (DTC)&#xD;
  &#xD;
            -  Previous total thyroidectomy&#xD;
  &#xD;
            -  Has either:&#xD;
  &#xD;
                 -  local lymph node metastases&#xD;
  &#xD;
                 -  distant mediastinal/cervical metastases&#xD;
  &#xD;
                 -  lung or osseous metastases as seen on prior imaging studies&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-iodine avid disease&#xD;
  &#xD;
            -  Under 18 years of age&#xD;
  &#xD;
            -  Unable to give consent&#xD;
  &#xD;
            -  Pregnant women, Non-viable neonates or neonates of uncertain viability.&#xD;
  &#xD;
            -  Non-English-speaking patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>SUNY Upstate Medical University</name>
        <address>
          <city>Syracuse</city>
          <state>New York</state>
          <zip>13210</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.</citation>
      <PMID>26462967</PMID>
    </reference>
    <reference>
      <citation>Willowson KP, Eslick EM, Bailey DL. Individualised dosimetry and safety of SIRT for intrahepatic cholangiocarcinoma. EJNMMI Phys. 2021 Sep 14;8(1):65. doi: 10.1186/s40658-021-00406-2.</citation>
      <PMID>34519900</PMID>
    </reference>
    <reference>
      <citation>Lubin DJ, Tsetse C, Khorasani MS, Allahyari M, McGrath M. Clinical predictors of I-131 therapy failure in differentiated thyroid cancer by machine learning: A single-center experience. World J Nucl Med. 2021 Mar 15;20(3):253-259. doi: 10.4103/wjnm.WJNM_104_20. eCollection 2021 Jul-Sep.</citation>
      <PMID>34703393</PMID>
    </reference>
    <reference>
      <citation>Lassmann M, Reiners C, Luster M. Dosimetry and thyroid cancer: the individual dosage of radioiodine. Endocr Relat Cancer. 2010 Jun 3;17(3):R161-72. doi: 10.1677/ERC-10-0071. Print 2010 Sep.</citation>
      <PMID>20448022</PMID>
    </reference>
    <reference>
      <citation>Ferris HA, Williams G, Parker JA, Garber JR. Therapeutic implications of diffuse hepatic uptake following I-131 therapy for differentiated thyroid cancer. Endocr Pract. 2013 Mar-Apr;19(2):263-7. doi: 10.4158/EP12077.OR.</citation>
      <PMID>23529347</PMID>
    </reference>
    <reference>
      <citation>Alan Selcuk N, Toklu T, Beykan S, Karaaslan SI. Evaluation of the dosimetry approaches in ablation treatment of thyroid cancer. J Appl Clin Med Phys. 2018 Jul;19(4):134-140. doi: 10.1002/acm2.12350. Epub 2018 Jun 1.</citation>
      <PMID>29858536</PMID>
    </reference>
    <reference>
      <citation>de Koster EJ, Sulaiman T, Hamming JF, Schepers A, Snel M, van Velden FHP, de Geus-Oei LF, Vriens D. Radioiodine in Differentiated Thyroid Carcinoma: Do We Need Diagnostic Pre-Ablation Iodine-123 Scintigraphy to Optimize Treatment? Diagnostics (Basel). 2021 Mar 19;11(3):553. doi: 10.3390/diagnostics11030553.</citation>
      <PMID>33808843</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>I-131</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thyroid Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>De-identified data will be the only information available for sharing purposes.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028282
  org study id: SUNYUMU 1642552
  nct id: NCT06028282
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  The goal of this clinical trial study is to(1) determine the tissue specific dose of I-131
        taken up by residing thyroid issue in the thyroid bed post-RAI along with any other sites in
        the neck and mediastinum as well as (2) correlate the dose delivered to residual tissues in
        the neck with patient follow-up based clinical outcomes, biochemical and imaging data
        following RAI therapy in patients with well-differentiated thyroid cancer (DTC). The main
        question[s] it aims to answer are:
  
          -  [question 1] How can obtained whole body and planar images more adequately depict
             residual iodine-avid disease in the thyroid bed, neck or mediastinum?
  
          -  [question 2] How can we obtain information on the dose taken up by the tumor remnant to
             know how much radionuclide actually went to the residual disease/tissue? Participants
             will [describe the main tasks participants will be asked to do, treatments they'll be
             given and use bullets if it is more than 2 items].
  In our current clinical practice, patients with well-differentiated thyroid cancer (DTC) who
        receive oral administration of radioiodine 1-131 (RAI) have whole body and planar images
        obtained 4-5 days post-treatment. These images often do not adequately depict residual
        iodine-avid disease in the thyroid bed, neck or mediastinum. Further, no information about
        what dose taken up by the tumor remnant is obtained and thus we are unable to know how much
        radionuclide actually went to the residual disease/tissue.
  
        Using single photon emission computed tomography (SPECT)/CT we will be able to better
        localize and evaluate disease/tissue remnant or distant iodine-avid metastatic disease. In
        addition, using Varian Velocity Theranostics Dosimetry suite of software applications, we
        will be able to do dosimetry on post-RAI therapy patients and be able to better correlate
        clinical outcomes with tumor absorbed dose in addition to provide quality improvement for the
        radioiodine ablation.
  observational model: Case-Control
  time perspective: Prospective
  measure: Staging Accuracy and Improved Clinical Patient Care
  time frame: 24 months
  description: In addition to providing a thorough evaluation for any iodine-avid disease in the thyroid bed, neck soft tissues and mediastinum, a SPECT/CT with a high-energy collimator will help better assess the clinical stage of disease at the time of RAI treatment. Thus, better staging accuracy will be obtained and this will improve clinical patient management
  arm group label: Radioiodine I-131 (RAI)
  description: oral administration of radioiodine I-131 (RAI) to patients with well-differentiated thyroid cancer
  intervention type: Radiation
  intervention name: SPECT
  description: SPECT of thyroid traced with I-131
  arm group label: Radioiodine I-131 (RAI)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  citation: Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
  PMID: 26462967
  citation: Willowson KP, Eslick EM, Bailey DL. Individualised dosimetry and safety of SIRT for intrahepatic cholangiocarcinoma. EJNMMI Phys. 2021 Sep 14;8(1):65. doi: 10.1186/s40658-021-00406-2.
  PMID: 34519900
  citation: Lubin DJ, Tsetse C, Khorasani MS, Allahyari M, McGrath M. Clinical predictors of I-131 therapy failure in differentiated thyroid cancer by machine learning: A single-center experience. World J Nucl Med. 2021 Mar 15;20(3):253-259. doi: 10.4103/wjnm.WJNM_104_20. eCollection 2021 Jul-Sep.
  PMID: 34703393
  citation: Lassmann M, Reiners C, Luster M. Dosimetry and thyroid cancer: the individual dosage of radioiodine. Endocr Relat Cancer. 2010 Jun 3;17(3):R161-72. doi: 10.1677/ERC-10-0071. Print 2010 Sep.
  PMID: 20448022
  citation: Ferris HA, Williams G, Parker JA, Garber JR. Therapeutic implications of diffuse hepatic uptake following I-131 therapy for differentiated thyroid cancer. Endocr Pract. 2013 Mar-Apr;19(2):263-7. doi: 10.4158/EP12077.OR.
  PMID: 23529347
  citation: Alan Selcuk N, Toklu T, Beykan S, Karaaslan SI. Evaluation of the dosimetry approaches in ablation treatment of thyroid cancer. J Appl Clin Med Phys. 2018 Jul;19(4):134-140. doi: 10.1002/acm2.12350. Epub 2018 Jun 1.
  PMID: 29858536
  citation: de Koster EJ, Sulaiman T, Hamming JF, Schepers A, Snel M, van Velden FHP, de Geus-Oei LF, Vriens D. Radioiodine in Differentiated Thyroid Carcinoma: Do We Need Diagnostic Pre-Ablation Iodine-123 Scintigraphy to Optimize Treatment? Diagnostics (Basel). 2021 Mar 19;11(3):553. doi: 10.3390/diagnostics11030553.
  PMID: 33808843
  responsible party type: Sponsor
  mesh term: Thyroid Diseases
  sharing ipd: No
  ipd description: De-identified data will be the only information available for sharing purposes.