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/NCT05966363</url>
    </required_header>
    <id_info>
      <org_study_id>2023/738</org_study_id>
      <nct_id>NCT05966363</nct_id>
    </id_info>
    <brief_title>Comparison of Cone Beam Irradiation Versus Multi-detector Scanner for Ear Imaging</brief_title>
    <acronym>ICSI</acronym>
    <official_title>Comparison of Cone Beam Irradiation Versus Multi-detector Scanner for Ear Imaging</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Besancon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Besancon</source>
    <oversight_info>
      <has_dmc>No</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>
        The primary objective of this study is to compare the irradiation between Cone Beam and CT of&#xD;
        the petrous bone.&#xD;
  &#xD;
        The primary endpoint is the measurement of equivalent doses per organ of interest (eyes,&#xD;
        ears, thyroid and external genitalia).&#xD;
  &#xD;
        The investigators have set up a prospective monocentric study. The investigators will measure&#xD;
        irradiation of these different organs using nanodots placed on the patient during imaging.&#xD;
  &#xD;
        The results of these measurements will be compared between Cone Beam (performed in the&#xD;
        Besançon University Hospital ENT department for cochlear implant position checks) and CT (all&#xD;
        indications combined).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>CT and CBCT induced Irradiation in ear imaging in adults with adult protocol</measure>
      <time_frame>9 month</time_frame>
      <description>To compare CT and CBCT induced irradiation in ear imaging in adults and children &gt; 15 years of age who have benefited from an adult protocol.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CT and CBCT induced Irradiation in ear imaging in children with Pediatric protocol</measure>
      <time_frame>9 month</time_frame>
      <description>To compare CT and CBCT induced irradiation in ear imaging in children ≤ 15 years of age who have benefited from a pediatric protocol.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CT and CBCT induced Irradiation in ear imaging in adults with pediatric protocol</measure>
      <time_frame>9 month</time_frame>
      <description>To compare CT and CBCT induced irradiation in ear imaging in adults and children &gt; 15 years of age who have benefited from a pediatric protocol.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Irradiation; Adverse Effect</condition>
    <arm_group>
      <arm_group_label>CBCT</arm_group_label>
      <description>Patients receiving a Cone Beam of the rocks as part of a cochlear implant position check at Besançon University Hospital</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CT</arm_group_label>
      <description>Patients receiving a CT scan of the rocks at Besançon University Hospital, all indications combined</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Nanodot</intervention_name>
      <description>Radiation measurements using nanodots placed on the eyes, ears, neck and lower abdomen during an imaging examination.</description>
      <arm_group_label>CBCT</arm_group_label>
      <arm_group_label>CT</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients are recruited during a consultation in the ENT department, either as part of a&#xD;
          pre-cochlear implant assessment, or as part of a prescription for a CT scan of the petrous&#xD;
          bone by the Besançon University Hospital ENT department department to be carried out at&#xD;
          Besançon University Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult or child patients of any gender and any age, including the pediatric population,&#xD;
               receiving a CT scan of the petrous bone performed at Besançon University Hospital and&#xD;
               prescribed in the Besançon University Hospital ENT department, or receiving a CBCT as&#xD;
               part of an intraoperative check of cochlear implant position.&#xD;
  &#xD;
            -  Women menopausal for at least 24 months, surgically sterilized, or, for women of&#xD;
               childbearing age, using an effective contraceptive method (oral contraceptives,&#xD;
               contraceptive injections, intra-uterine devices, double-barrier method, contraceptive&#xD;
               patches).&#xD;
  &#xD;
            -  Subject's non-opposition to study participation&#xD;
  &#xD;
            -  Affiliation with a French social security scheme or beneficiary of such a scheme.&#xD;
  &#xD;
          Exclusion criteria are :&#xD;
  &#xD;
            -  Legal incapacity or limited legal capacity&#xD;
  &#xD;
            -  Subject unlikely to cooperate with the study and/or poor cooperation anticipated by&#xD;
               the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Anne-Line MUTSCHLER, MD</last_name>
      <phone>+33381668238</phone>
      <email>almutschler@chu-besancon.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Astrid POZET, Msc</last_name>
      <phone>+33381218988</phone>
      <email>apozet@chu-besancon.fr</email>
    </overall_contact_backup>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>irradiation</keyword>
    <keyword>TDM</keyword>
    <keyword>Cone Beam</keyword>
    <keyword>CT</keyword>
    <keyword>CBCT</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05966363
  org study id: 2023/738
  nct id: NCT05966363
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this study is to compare the irradiation between Cone Beam and CT of
        the petrous bone.
  
        The primary endpoint is the measurement of equivalent doses per organ of interest (eyes,
        ears, thyroid and external genitalia).
  
        The investigators have set up a prospective monocentric study. The investigators will measure
        irradiation of these different organs using nanodots placed on the patient during imaging.
  
        The results of these measurements will be compared between Cone Beam (performed in the
        Besançon University Hospital ENT department for cochlear implant position checks) and CT (all
        indications combined).
  observational model: Cohort
  time perspective: Prospective
  measure: CT and CBCT induced Irradiation in ear imaging in adults with adult protocol
  time frame: 9 month
  description: To compare CT and CBCT induced irradiation in ear imaging in adults and children > 15 years of age who have benefited from an adult protocol.
  measure: CT and CBCT induced Irradiation in ear imaging in children with Pediatric protocol
  time frame: 9 month
  description: To compare CT and CBCT induced irradiation in ear imaging in children ≤ 15 years of age who have benefited from a pediatric protocol.
  measure: CT and CBCT induced Irradiation in ear imaging in adults with pediatric protocol
  time frame: 9 month
  description: To compare CT and CBCT induced irradiation in ear imaging in adults and children > 15 years of age who have benefited from a pediatric protocol.
  arm group label: CBCT
  description: Patients receiving a Cone Beam of the rocks as part of a cochlear implant position check at Besançon University Hospital
  arm group label: CT
  description: Patients receiving a CT scan of the rocks at Besançon University Hospital, all indications combined
  intervention type: Radiation
  intervention name: Nanodot
  description: Radiation measurements using nanodots placed on the eyes, ears, neck and lower abdomen during an imaging examination.
  arm group label: CBCT
  arm group label: CT
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Anne-Line MUTSCHLER, MD
  phone: +33381668238
  email: almutschler@chu-besancon.fr
  last name: Astrid POZET, Msc
  phone: +33381218988
  email: apozet@chu-besancon.fr
  responsible party type: Sponsor
  sharing ipd: No