<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/NCT03250195</url>
  </required_header>
  <id_info>
    <org_study_id>H-17013319</org_study_id>
    <nct_id>NCT03250195</nct_id>
  </id_info>
  <brief_title>Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)</brief_title>
  <official_title>Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</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 aim of the study is to examine the value of the new MRI techniques (spectroscopy and&#xD;
      DWI), and FDG-PET in prognostication of male infertility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The diagnostic workup of male infertility includes medical history, physical examination and&#xD;
      semen analysis. In severe cases further workup includes testicular ultrasound, analysis of&#xD;
      genes and hormones and in a few cases testicular biopsies are necessary.&#xD;
&#xD;
      Ultrasound is the first choice of imaging, but new MRI and PET techniques can provide&#xD;
      additional information.&#xD;
&#xD;
      Research indicates that new MRI techniques can measure the activity of the testicular sperm&#xD;
      cell production non-invasively and FDG-PET can measure the testicular metabolism with a&#xD;
      radioactively marked glucose analog (FDG). These imaging modalities are combined in a PET/MRI&#xD;
      and we wish to perform a PET/MRI in 10 men with normal sperm counts and 10 men with low sperm&#xD;
      counts in order to evaluate whether a PET/MRI can distinguish testicles with and without&#xD;
      sperm cell production. We hope that this new non-invasive technique can replace the need for&#xD;
      invasive biopsies and will be able to target the harvesting of sperm cells in fertility&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient inclusion of patients&#xD;
  </why_stopped>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">August 7, 2021</completion_date>
  <primary_completion_date type="Actual">August 7, 2021</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SUVmax (maximum standardized uptake value)</measure>
    <time_frame>1 year</time_frame>
    <description>The SUV is the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Testicular metabolite concentrations measured by MRI spectroscopy.</measure>
    <time_frame>1 year</time_frame>
    <description>MR spectroscopy is a non-invasive, ionizing-radiation-free analytical technique that has been used to study metabolic changes in different tissues. The unit is p.p.m.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Testicular apparent diffusion coefficient</measure>
    <time_frame>1 year</time_frame>
    <description>Diffusion-weighted magnetic resonance imaging (DW MRI) provides image contrast that is dependent on the random microscopic motion of water protons, which may be substantially altered by different pathological process.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Fertility Disorders</condition>
  <arm_group>
    <arm_group_label>PET/MRI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participants will have a PET/MRI performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PET/MRI</intervention_name>
    <description>PET/MRI scan</description>
    <arm_group_label>PET/MRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        18-40 year old males referred to fertility treatment at Rigshospitalet, Denmark. 10 men&#xD;
        with a normal sperm count and 10 men with no sperm cells in the ejaculate will be included.&#xD;
        The patients shall be able to understand the patient information and be able to give&#xD;
        informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Severe claustrophobia Age: less than 18 or above 40 Severe obesity (&gt; 140 kg) Pacemaker or&#xD;
        other electronic in-operated devices Non-MR compatible metallic devices Malignant&#xD;
        testicular tumors suspected at clinical examination or ultrasound Infectious testicular&#xD;
        diseases&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>We examine testicular function and therefore we only include men</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Louise Risør</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <state>Østerbro</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Louise Madeleine Risør</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Male</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The results will be published in international journals</ipd_description>
  </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/NCT03250195
org study id: H-17013319
nct id: NCT03250195
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to examine the value of the new MRI techniques (spectroscopy and
      DWI), and FDG-PET in prognostication of male infertility.
The diagnostic workup of male infertility includes medical history, physical examination and
      semen analysis. In severe cases further workup includes testicular ultrasound, analysis of
      genes and hormones and in a few cases testicular biopsies are necessary.

      Ultrasound is the first choice of imaging, but new MRI and PET techniques can provide
      additional information.

      Research indicates that new MRI techniques can measure the activity of the testicular sperm
      cell production non-invasively and FDG-PET can measure the testicular metabolism with a
      radioactively marked glucose analog (FDG). These imaging modalities are combined in a PET/MRI
      and we wish to perform a PET/MRI in 10 men with normal sperm counts and 10 men with low sperm
      counts in order to evaluate whether a PET/MRI can distinguish testicles with and without
      sperm cell production. We hope that this new non-invasive technique can replace the need for
      invasive biopsies and will be able to target the harvesting of sperm cells in fertility
      treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: SUVmax (maximum standardized uptake value)
time frame: 1 year
description: The SUV is the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity.
measure: Testicular metabolite concentrations measured by MRI spectroscopy.
time frame: 1 year
description: MR spectroscopy is a non-invasive, ionizing-radiation-free analytical technique that has been used to study metabolic changes in different tissues. The unit is p.p.m.
measure: Testicular apparent diffusion coefficient
time frame: 1 year
description: Diffusion-weighted magnetic resonance imaging (DW MRI) provides image contrast that is dependent on the random microscopic motion of water protons, which may be substantially altered by different pathological process.
arm group label: PET/MRI
arm group type: Other
description: All participants will have a PET/MRI performed
intervention type: Diagnostic Test
intervention name: PET/MRI
description: PET/MRI scan
arm group label: PET/MRI
criteria: 
gender: Male
gender based: Yes
gender description: We examine testicular function and therefore we only include men
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Louise Risør
role: Principal Investigator
affiliation: Rigshospitalet, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Louise Madeleine Risør
investigator title: MD
mesh term: Infertility
mesh term: Infertility, Male
sharing ipd: No
ipd description: The results will be published in international journals