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/NCT05963841</url>
    </required_header>
    <id_info>
      <org_study_id>2023/796</org_study_id>
      <nct_id>NCT05963841</nct_id>
    </id_info>
    <brief_title>NUclear MEdicine DIagnostic and Artificial Intelligence</brief_title>
    <acronym>NUMEDIA</acronym>
    <official_title>Contribution to Disease Diagnosis and Prognosis Based on the Fusion of Expert Knowledge, Nuclear Medicine Imaging and Artificial Intelligence (AI) Tools</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Besancon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Franche-Comté Electronique Mécanique Thermique et Optique - Sciences et Technologies, UMR 6174</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Besancon</source>
    <brief_summary>
      <textblock>
        Artificial intelligence algorithms for parathyroid adenoma detection in parathyroid scans The&#xD;
        aim of the study is to develop programs for the automatic subtraction of planar and&#xD;
        tomographic parathyroid images and for the localization of parathyroid adenomas using&#xD;
        artificial intelligence tools.&#xD;
  &#xD;
        Inclusion criteria Patients having undergone a double isotope parathyroid diagnostic&#xD;
        examination using the standard Besançon University Hospital protocol (double injection of&#xD;
        123I and 99mTc, pinhole image, low energy high resolution (LEHR) and (single-photon emission&#xD;
        tomography / Computed tomography) SPECT/CT +/- (positron emission tomography (PET) Choline).&#xD;
  &#xD;
        Secondary endpoints Concordance between diagnoses made by nuclear physicians using both&#xD;
        methods (current method and new treatment method).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        State of the art :&#xD;
  &#xD;
        Planar scintigraphy of the parathyroid glands offers good diagnostic performance. The&#xD;
        introduction of SPECT coupled with CT ten years ago has improved anatomical location,&#xD;
        facilitating surgery.&#xD;
  &#xD;
        With dual-isotope scans, the physician has to subtract the images to highlight the&#xD;
        parathyroid adenomas, and use the SPECT/CT slices to pinpoint the exact location of the&#xD;
        adenomas.&#xD;
  &#xD;
        Several software packages, supplied by nuclear medicine image processing software publishers,&#xD;
        are available on the market, but they require numerous actions on the part of doctors, which&#xD;
        reduce reproducibility and necessitate a learning curve for the physician.&#xD;
  &#xD;
        Research Hypothesis :&#xD;
  &#xD;
        The images were taken as part of the patient's diagnosis, without any additional acquisition&#xD;
        compared with clinical routine.&#xD;
  &#xD;
        Acquisitions were of good quality, with good centering of the thyroid on the images.&#xD;
  &#xD;
        The 3 Pinhole, LEHR and SPECT/CT acquisitions were performed after injection of Iodine 123&#xD;
        and 3 hours after Technetium 99m.&#xD;
  &#xD;
        Expected results :&#xD;
  &#xD;
        Creation of a program for automatic subtraction of planar and tomographic images. Use&#xD;
        artificial intelligence algorithms to help doctors with their diagnosis.&#xD;
  &#xD;
        Main objective :&#xD;
  &#xD;
        Development of an artificial intelligence-based diagnostic assistance program.&#xD;
  &#xD;
        Secondary objectives :&#xD;
  &#xD;
        Creation of an automatic program for subtracting double-isotope parathyroid images. This&#xD;
        image processing is a prerequisite for artificial intelligence analysis methods.&#xD;
  &#xD;
        Inclusion Criteria :&#xD;
  &#xD;
        Men and women over 18 years of age who have undergone double-isotope parathyroid&#xD;
        scintigraphy.&#xD;
  &#xD;
        No refusal to use data for research purposes Retrospective (after 13/04/2022: Date of posting&#xD;
        of patient information in the department) and prospective data&#xD;
  &#xD;
        Non-inclusion criteria :&#xD;
  &#xD;
        Patient refusal to use data for research purposes Patients who did not benefit from the&#xD;
        standard acquisition protocol (123I injection followed by 99mTc 3 hours after LEHR, PINHOLE&#xD;
        and SPECT/CT acquisitions).&#xD;
  &#xD;
        Description of research methodology :&#xD;
  &#xD;
        Retrospective and prospective study using data from the medical records of patients meeting&#xD;
        the eligibility criteria. No additional examinations were carried out on the patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Development of an artificial intelligence diagnostic program</measure>
      <time_frame>through study completion, an average of 4 years</time_frame>
      <description>Development of an artificial intelligence diagnostic program</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Development of an automatic program for subtracting double-isotope parathyroid images.</measure>
      <time_frame>through study completion, an average of 2 years</time_frame>
      <description>Development of an automatic program for subtracting double-isotope parathyroid images.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1</enrollment>
    <condition>Hyperparathyroidism</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>treatment program</intervention_name>
      <description>the study aims to set up an artificial intelligence diagnostic assistance program</description>
      <other_name>diagnostic assistance program</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Men and women over 18 years of age who have undergone dual-isotope parathyroid scintigraphy&#xD;
          (standard acquisition protocol (123I injection followed by 99mTc 3 hours after LEHR,&#xD;
          PINHOLE and SPECT/CT acquisitions).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men and women over 18 years of age who underwent dual-isotope parathyroid&#xD;
               scintigraphy.&#xD;
  &#xD;
            -  No refusal to use data for research purposes&#xD;
  &#xD;
            -  Retrospective data (after 13/04/2022: Date of posting of patient information in the&#xD;
               department) and prospective data&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refusal to use data for research purposes&#xD;
  &#xD;
            -  Patients who did not benefit from the standard acquisition protocol (123I injection&#xD;
               followed by 99mTc 3 hours after LEHR, PINHOLE and SPECT/CT acquisitions)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>scintigraphy</keyword>
    <keyword>parathyroid</keyword>
    <keyword>SPECT/CT</keyword>
    <keyword>Intelligence artificial</keyword>
    <keyword>dual isotope</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperparathyroidism</mesh_term>
    </condition_browse>
    <!-- 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/NCT05963841
  org study id: 2023/796
  nct id: NCT05963841
  lead sponsor: 
  collaborator: 
  Artificial intelligence algorithms for parathyroid adenoma detection in parathyroid scans The
        aim of the study is to develop programs for the automatic subtraction of planar and
        tomographic parathyroid images and for the localization of parathyroid adenomas using
        artificial intelligence tools.
  
        Inclusion criteria Patients having undergone a double isotope parathyroid diagnostic
        examination using the standard Besançon University Hospital protocol (double injection of
        123I and 99mTc, pinhole image, low energy high resolution (LEHR) and (single-photon emission
        tomography / Computed tomography) SPECT/CT +/- (positron emission tomography (PET) Choline).
  
        Secondary endpoints Concordance between diagnoses made by nuclear physicians using both
        methods (current method and new treatment method).
  State of the art :
  
        Planar scintigraphy of the parathyroid glands offers good diagnostic performance. The
        introduction of SPECT coupled with CT ten years ago has improved anatomical location,
        facilitating surgery.
  
        With dual-isotope scans, the physician has to subtract the images to highlight the
        parathyroid adenomas, and use the SPECT/CT slices to pinpoint the exact location of the
        adenomas.
  
        Several software packages, supplied by nuclear medicine image processing software publishers,
        are available on the market, but they require numerous actions on the part of doctors, which
        reduce reproducibility and necessitate a learning curve for the physician.
  
        Research Hypothesis :
  
        The images were taken as part of the patient's diagnosis, without any additional acquisition
        compared with clinical routine.
  
        Acquisitions were of good quality, with good centering of the thyroid on the images.
  
        The 3 Pinhole, LEHR and SPECT/CT acquisitions were performed after injection of Iodine 123
        and 3 hours after Technetium 99m.
  
        Expected results :
  
        Creation of a program for automatic subtraction of planar and tomographic images. Use
        artificial intelligence algorithms to help doctors with their diagnosis.
  
        Main objective :
  
        Development of an artificial intelligence-based diagnostic assistance program.
  
        Secondary objectives :
  
        Creation of an automatic program for subtracting double-isotope parathyroid images. This
        image processing is a prerequisite for artificial intelligence analysis methods.
  
        Inclusion Criteria :
  
        Men and women over 18 years of age who have undergone double-isotope parathyroid
        scintigraphy.
  
        No refusal to use data for research purposes Retrospective (after 13/04/2022: Date of posting
        of patient information in the department) and prospective data
  
        Non-inclusion criteria :
  
        Patient refusal to use data for research purposes Patients who did not benefit from the
        standard acquisition protocol (123I injection followed by 99mTc 3 hours after LEHR, PINHOLE
        and SPECT/CT acquisitions).
  
        Description of research methodology :
  
        Retrospective and prospective study using data from the medical records of patients meeting
        the eligibility criteria. No additional examinations were carried out on the patient.
  observational model: Cohort
  time perspective: Other
  measure: Development of an artificial intelligence diagnostic program
  time frame: through study completion, an average of 4 years
  description: Development of an artificial intelligence diagnostic program
  measure: Development of an automatic program for subtracting double-isotope parathyroid images.
  time frame: through study completion, an average of 2 years
  description: Development of an automatic program for subtracting double-isotope parathyroid images.
  intervention type: Device
  intervention name: treatment program
  description: the study aims to set up an artificial intelligence diagnostic assistance program
  other name: diagnostic assistance program
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  responsible party type: Sponsor
  mesh term: Hyperparathyroidism