<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/NCT03242811</url>
  </required_header>
  <id_info>
    <org_study_id>SAAS 20170506</org_study_id>
    <nct_id>NCT03242811</nct_id>
  </id_info>
  <brief_title>Swedish Age Assessment Study</brief_title>
  <acronym>SAAS</acronym>
  <official_title>Swedish Age Assessment Study -SAAS Study to Deepen the Knowledge of Magnetic Camera Examinations as a Method for Medical Age Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Berit Larsson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Blekinge Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health and Social Affairs, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</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>
      It is important that asylum seekers should have as accurate age assessment as possible and&#xD;
      that children's fundamental rights are met by choosing methods based on best available&#xD;
      knowledge. The aim is to provide, on the basis of best available knowledge, suggestions for&#xD;
      methods of medical age assessment of whether a person is over or under 18 years of age.&#xD;
&#xD;
      The primary issue is to investigate whether five selected growth zones in knee joint, ankle&#xD;
      and wrist individually or in combination can better determine the 18-year limit compared with&#xD;
      previous research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Swedish Age Assessment study is conducted with the aim of&#xD;
&#xD;
        -  Deepening the knowledge of age-assessment methodology with magnetic camera examinations&#xD;
           among born and registered in Sweden aged 14.0 through 21.5 years&#xD;
&#xD;
        -  With a magnetic camera, investigate whether five selected growth zones in the knee joint&#xD;
           and ankle joint (distal femur, proximal tibia, distal tibia and calcaneus) and distal&#xD;
           radius (wrist) individually or in combination can better determine the 18-year limit&#xD;
           compared with previous research&#xD;
&#xD;
        -  To investigate how gender and growing environment can affect the end of growth zones&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2017</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with correctly classified age (below or above 18 years) when 5 different growth zones in the knee, ankle and wrist are examined by MRI and analysed individually and in combination to determine the maturity.</measure>
    <time_frame>1 day</time_frame>
    <description>With 1.5 Tesla magnetic camera with dedicated cartilage sequence, selected growth zones will be investigated: knee joint, ankle joint including heel leg and wrist. The non-dominant body half will be investigated. In order to evaluate the growth zone with the highest precision, we have chosen T2-weighted gradient-recalled echo sequence, called mFFE / MERGE® / MEDIC® by various suppliers. The sequence is used in the clinical practice to assess various types of abnormalities in the cartilage. Two independent and blinded child radiologists shall examine MR images of 5 growth zones of each participant. All sections of each growth zone are to be examined and the cut is selected which shows the highest degree of closing / maturity for grading. Each growth zone will be examined and classified as being mature or non-mature.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">958</enrollment>
  <condition>Age Determination by Skeleton</condition>
  <arm_group>
    <arm_group_label>Examination by MRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MRI scan of knee, ankle and wrist</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI scan of knee, ankle and wrist</intervention_name>
    <description>At the day of the intervention, the subject is informed about the study by a nurse and provides written informed consent.&#xD;
Girls must leave urine tests to rule out pregnancy. The questionnaire for the study is answered by the subject and weight and length are measured. The subject is asked to self-assess his/her puberty.&#xD;
After detailed information on how a magnetic camera examination is carried out, an examination of five selected growth zones (knee joint, ankle joint including heel leg and wrist) is performed using 1.5 Tesla magnetic camera with dedicated cartilage sequence.</description>
    <arm_group_label>Examination by MRI</arm_group_label>
    <other_name>Self assessment of puberty by Tanner scale</other_name>
    <other_name>Questionnaire on socioeconomics</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy children / young adults without prior illness (such as asthma, growth hormone&#xD;
             treatment, prolonged peroral cortisone treatment, cancer treatment, diabetes,&#xD;
             rheumatic disease) that may have affected growth can be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children or adolescents with ongoing drug treatment for chronic disease.&#xD;
&#xD;
          -  Contraindication against MRI examination&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra Diaz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Johan Sanmartin Berglund, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Blekinge Institute of Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carl-Erik Flodmark, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Ministry of Health and Social Affairs, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Blekinge Institute of Technology</name>
      <address>
        <city>Karlskrona</city>
        <zip>37179</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Institute</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>June 5, 2018</last_update_submitted>
  <last_update_submitted_qc>June 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Berit Larsson</investigator_full_name>
    <investigator_title>Unit Manager Karolinska Trial Alliance</investigator_title>
  </responsible_party>
  <keyword>Medical age assessment</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03242811
org study id: SAAS 20170506
nct id: NCT03242811
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is important that asylum seekers should have as accurate age assessment as possible and
      that children's fundamental rights are met by choosing methods based on best available
      knowledge. The aim is to provide, on the basis of best available knowledge, suggestions for
      methods of medical age assessment of whether a person is over or under 18 years of age.

      The primary issue is to investigate whether five selected growth zones in knee joint, ankle
      and wrist individually or in combination can better determine the 18-year limit compared with
      previous research.
Swedish Age Assessment study is conducted with the aim of

        -  Deepening the knowledge of age-assessment methodology with magnetic camera examinations
           among born and registered in Sweden aged 14.0 through 21.5 years

        -  With a magnetic camera, investigate whether five selected growth zones in the knee joint
           and ankle joint (distal femur, proximal tibia, distal tibia and calcaneus) and distal
           radius (wrist) individually or in combination can better determine the 18-year limit
           compared with previous research

        -  To investigate how gender and growing environment can affect the end of growth zones
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of participants with correctly classified age (below or above 18 years) when 5 different growth zones in the knee, ankle and wrist are examined by MRI and analysed individually and in combination to determine the maturity.
time frame: 1 day
description: With 1.5 Tesla magnetic camera with dedicated cartilage sequence, selected growth zones will be investigated: knee joint, ankle joint including heel leg and wrist. The non-dominant body half will be investigated. In order to evaluate the growth zone with the highest precision, we have chosen T2-weighted gradient-recalled echo sequence, called mFFE / MERGE® / MEDIC® by various suppliers. The sequence is used in the clinical practice to assess various types of abnormalities in the cartilage. Two independent and blinded child radiologists shall examine MR images of 5 growth zones of each participant. All sections of each growth zone are to be examined and the cut is selected which shows the highest degree of closing / maturity for grading. Each growth zone will be examined and classified as being mature or non-mature.
arm group label: Examination by MRI
arm group type: Experimental
description: MRI scan of knee, ankle and wrist
intervention type: Diagnostic Test
intervention name: MRI scan of knee, ankle and wrist
description: At the day of the intervention, the subject is informed about the study by a nurse and provides written informed consent.
Girls must leave urine tests to rule out pregnancy. The questionnaire for the study is answered by the subject and weight and length are measured. The subject is asked to self-assess his/her puberty.
After detailed information on how a magnetic camera examination is carried out, an examination of five selected growth zones (knee joint, ankle joint including heel leg and wrist) is performed using 1.5 Tesla magnetic camera with dedicated cartilage sequence.
arm group label: Examination by MRI
other name: Self assessment of puberty by Tanner scale
other name: Questionnaire on socioeconomics
criteria: 
gender: All
minimum age: 14 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sandra Diaz, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Johan Sanmartin Berglund, MD, PhD
role: Principal Investigator
affiliation: Blekinge Institute of Technology
last name: Carl-Erik Flodmark, MD, PhD
role: Study Director
affiliation: Ministry of Health and Social Affairs, Sweden
facility: 
facility: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Berit Larsson
investigator title: Unit Manager Karolinska Trial Alliance
sharing ipd: No