<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/NCT02967666</url>
  </required_header>
  <id_info>
    <org_study_id>DOTANOC_contacts</org_study_id>
    <nct_id>NCT02967666</nct_id>
  </id_info>
  <brief_title>Evaluation of PET/MRI Using a Somatostatin Analog Tracer as a Novel Approach to Detecting Pathology in High Risk TB-exposed Contacts</brief_title>
  <official_title>Evaluation of PET/MRI Using a Somatostatin Analog Tracer as a Novel Approach to Detecting Pathology in High Risk TB-exposed Contacts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University Hospital, Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      PET/MRI (positron emission tomography/magnetic resonance imaging) with somatostatin analog&#xD;
      tracers has the potential to provide an imaging technique targeting subclinical granulomatous&#xD;
      disease in those with latent tuberculosis (TB), allowing identification of individuals who&#xD;
      may be at risk of progression to active TB.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Granulomas, the hallmark of TB infection, have an increased density of somatostatin&#xD;
      receptors. Somatostatin analog PET tracers, such as 68Ga-DOTANOC, bind to somatostatin&#xD;
      receptors and are able to detect pulmonary TB lesions using PET/MRI. This study aims to&#xD;
      better understand the pathology of the spectrum of latent TB using 68Ga-DOTANOC PET/MRI&#xD;
      imaging, identifying individuals with subclinical pulmonary TB who may be at risk of&#xD;
      progressing to active TB.&#xD;
&#xD;
      Currently, biomarkers to identify those who are at risk of developing active TB are limited.&#xD;
      Non-invasive biomarkers for pulmonary lesions are sorely needed and imaging with 68Ga-DOTANOC&#xD;
      PET/MRI provides an opportunity to detect subclinical pulmonary disease in those who have&#xD;
      been in close contact with smear-positive pulmonary TB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <phase>Phase 1</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>Standard uptake value (SUV) of 68Ga-DOTANOC in subclinical TB using PET/MRI</measure>
    <time_frame>Within 2 months of exposure to smear-positive pulmonary TB</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Tuberculosis, Pulmonary</condition>
  <arm_group>
    <arm_group_label>FDG PET/MRI, DOTANOC PET/MRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FDG PET/MRI and DOTANOC PET/MRI will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>FDG ligand</intervention_name>
    <arm_group_label>FDG PET/MRI, DOTANOC PET/MRI</arm_group_label>
    <other_name>18F-Fludeoxyglucose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>DOTANOC ligand</intervention_name>
    <arm_group_label>FDG PET/MRI, DOTANOC PET/MRI</arm_group_label>
    <other_name>68Ga-DOTANOC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 21 years or over&#xD;
&#xD;
          2. Close household contact of any patient with newly-diagnosed (within last 2 months)&#xD;
             smear positive pulmonary TB (close contact defined as sleeping in the same house for&#xD;
             at least one month with a TB patient prior to start of treatment).&#xD;
&#xD;
          3. Interferon Gamma Release Assay (IGRA) positive&#xD;
&#xD;
          4. Willing to comply with the study visits and procedures&#xD;
&#xD;
          5. Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous treatment for TB disease&#xD;
&#xD;
          2. Diabetes that is, in the judgment of the investigator, so poorly controlled that it&#xD;
             would prevent adequate PET scanning&#xD;
&#xD;
          3. Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI&#xD;
&#xD;
          4. Occupation involving substantial exposure to radiation&#xD;
&#xD;
          5. Malignancy requiring chemotherapy or radiation&#xD;
&#xD;
          6. Known lung disease which may affect interpretation of the scan&#xD;
&#xD;
          7. Known chronic kidney disease&#xD;
&#xD;
          8. Symptoms, signs and/or previous investigations suggestive of active TB in the opinion&#xD;
             of the investigator (cough for &gt;1 month, cough productive of sputum or blood,&#xD;
             shortness of breath, weight loss, night sweats, fever, abnormal examination, chest&#xD;
             X-ray findings)&#xD;
&#xD;
          9. Women who are currently pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicholas Paton</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Hospital, Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claire Naftalin</last_name>
    <phone>(65) 6601 5373</phone>
    <email>claire_naftalin@nuhs.edu.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Naftalin</last_name>
      <phone>(65) 6601 5373</phone>
      <email>claire_naftalin@nuhs.edu.sg</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonny YT Wang</last_name>
      <phone>(65) 6511 5131</phone>
    </contact>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Pulmonary</mesh_term>
  </condition_browse>
  <!-- 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/NCT02967666
org study id: DOTANOC_contacts
nct id: NCT02967666
lead sponsor: 
has dmc: No
PET/MRI (positron emission tomography/magnetic resonance imaging) with somatostatin analog
      tracers has the potential to provide an imaging technique targeting subclinical granulomatous
      disease in those with latent tuberculosis (TB), allowing identification of individuals who
      may be at risk of progression to active TB.
Granulomas, the hallmark of TB infection, have an increased density of somatostatin
      receptors. Somatostatin analog PET tracers, such as 68Ga-DOTANOC, bind to somatostatin
      receptors and are able to detect pulmonary TB lesions using PET/MRI. This study aims to
      better understand the pathology of the spectrum of latent TB using 68Ga-DOTANOC PET/MRI
      imaging, identifying individuals with subclinical pulmonary TB who may be at risk of
      progressing to active TB.

      Currently, biomarkers to identify those who are at risk of developing active TB are limited.
      Non-invasive biomarkers for pulmonary lesions are sorely needed and imaging with 68Ga-DOTANOC
      PET/MRI provides an opportunity to detect subclinical pulmonary disease in those who have
      been in close contact with smear-positive pulmonary TB.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Standard uptake value (SUV) of 68Ga-DOTANOC in subclinical TB using PET/MRI
time frame: Within 2 months of exposure to smear-positive pulmonary TB
arm group label: FDG PET/MRI, DOTANOC PET/MRI
arm group type: Experimental
description: FDG PET/MRI and DOTANOC PET/MRI will be performed.
intervention type: Radiation
intervention name: FDG ligand
arm group label: FDG PET/MRI, DOTANOC PET/MRI
other name: 18F-Fludeoxyglucose
intervention type: Radiation
intervention name: DOTANOC ligand
arm group label: FDG PET/MRI, DOTANOC PET/MRI
other name: 68Ga-DOTANOC
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Nicholas Paton
role: Principal Investigator
affiliation: National University Hospital, Singapore
last name: Claire Naftalin
phone: (65) 6601 5373
email: claire_naftalin@nuhs.edu.sg
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Singapore
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Tuberculosis, Pulmonary