<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/NCT02972697</url>
  </required_header>
  <id_info>
    <org_study_id>11C_acetate</org_study_id>
    <nct_id>NCT02972697</nct_id>
  </id_info>
  <brief_title>Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB</brief_title>
  <official_title>Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB</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>
      Imaging using 11C-acetate PET (positron emission tomography) in patients with tuberculosis&#xD;
      (TB) may be able to detect non-replicating persister bacilli. This may permit identification&#xD;
      of those patients at risk of relapse following completion of TB treatment. The main aim of&#xD;
      this pilot study is to assess the ability of 11C-acetate PET to detect pulmonary lesions in&#xD;
      individuals with active pulmonary TB.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Novel biomarkers for detecting pulmonary TB and response to treatment are sorely needed. PET&#xD;
      in conjunction with either CT (computed tomography) or MRI (magnetic resonance imaging)&#xD;
      scanning allows assessment of the metabolic activity of lesions as well as the structural&#xD;
      anatomy of the lung. The standard radiolabelled tracer for PET is 18F-fluorodeoxyglucose&#xD;
      (FDG) which labels metabolically active cells. However, one of the main limitations of FDG is&#xD;
      the non-specific uptake leading to difficulty differentiating between tumours, infection and&#xD;
      inflammatory pathologies.&#xD;
&#xD;
      11C-acetate is a PET ligand used currently to image various conditions but has not been used&#xD;
      to identify TB lesions previously. 11C-acetate may be taken up by the lipid bodies in the&#xD;
      dormant bacteria in TB, enabling visualization of this sub-population of bacteria. Using the&#xD;
      11C-acetate ligand for imaging pulmonary TB may add to the utility of PET scanning,&#xD;
      potentially allowing monitoring of drug activity against the persister population and&#xD;
      identification of those patients who may be at risk of relapse following drug therapy.&#xD;
&#xD;
      This pilot study will compare 11C-acetate to the standard ligand, FDG, using PET/CT and&#xD;
      PET/MRI. The target population for this study is those individuals with confirmed pulmonary&#xD;
      TB who have a high chance of demonstrable bacillary burden who are therefore likely to have&#xD;
      populations of persister bacteria in the lungs.&#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">September 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 11C-acetate PET in pulmonary TB lesions</measure>
    <time_frame>Within 8 weeks of starting TB treatment</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Tuberculosis, Pulmonary</condition>
  <arm_group>
    <arm_group_label>11C-acetate PET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>11C-acetate and FDG PET/MRI and PET/CT will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>11C-acetate ligand</intervention_name>
    <arm_group_label>11C-acetate PET</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>FDG ligand</intervention_name>
    <arm_group_label>11C-acetate PET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 21 years and above&#xD;
&#xD;
          2. Willing to comply with the study visits and procedures&#xD;
&#xD;
          3. Willing and able to provide written informed consent&#xD;
&#xD;
          4. Clinical diagnosis of pulmonary TB with characteristic symptoms and compatible X-ray&#xD;
             findings plus microbiological confirmation with one or more of (i) Acid-fast bacilli&#xD;
             (AFB) smear-positive or (ii) molecular test positive or (iii) TB culture positive.&#xD;
             Tests done at any time during the current episode of TB are acceptable for diagnostic&#xD;
             purposes&#xD;
&#xD;
          5. Not on TB treatment or have completed less than 8 weeks of TB treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diabetes that is, in the judgment of the investigator, so poorly controlled that it&#xD;
             would prevent adequate PET scanning&#xD;
&#xD;
          2. Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI&#xD;
&#xD;
          3. Known chronic kidney disease&#xD;
&#xD;
          4. Occupation involving substantial exposure to radiation&#xD;
&#xD;
          5. History of medical procedures in the last year involving substantial exposure to&#xD;
             radiation (&gt;2mSv)&#xD;
&#xD;
          6. Malignancy requiring chemotherapy or radiation&#xD;
&#xD;
          7. 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 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>April 12, 2017</last_update_submitted>
  <last_update_submitted_qc>April 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</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/NCT02972697
org study id: 11C_acetate
nct id: NCT02972697
lead sponsor: 
has dmc: No
Imaging using 11C-acetate PET (positron emission tomography) in patients with tuberculosis
      (TB) may be able to detect non-replicating persister bacilli. This may permit identification
      of those patients at risk of relapse following completion of TB treatment. The main aim of
      this pilot study is to assess the ability of 11C-acetate PET to detect pulmonary lesions in
      individuals with active pulmonary TB.
Novel biomarkers for detecting pulmonary TB and response to treatment are sorely needed. PET
      in conjunction with either CT (computed tomography) or MRI (magnetic resonance imaging)
      scanning allows assessment of the metabolic activity of lesions as well as the structural
      anatomy of the lung. The standard radiolabelled tracer for PET is 18F-fluorodeoxyglucose
      (FDG) which labels metabolically active cells. However, one of the main limitations of FDG is
      the non-specific uptake leading to difficulty differentiating between tumours, infection and
      inflammatory pathologies.

      11C-acetate is a PET ligand used currently to image various conditions but has not been used
      to identify TB lesions previously. 11C-acetate may be taken up by the lipid bodies in the
      dormant bacteria in TB, enabling visualization of this sub-population of bacteria. Using the
      11C-acetate ligand for imaging pulmonary TB may add to the utility of PET scanning,
      potentially allowing monitoring of drug activity against the persister population and
      identification of those patients who may be at risk of relapse following drug therapy.

      This pilot study will compare 11C-acetate to the standard ligand, FDG, using PET/CT and
      PET/MRI. The target population for this study is those individuals with confirmed pulmonary
      TB who have a high chance of demonstrable bacillary burden who are therefore likely to have
      populations of persister bacteria in the lungs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Standard uptake value (SUV) of 11C-acetate PET in pulmonary TB lesions
time frame: Within 8 weeks of starting TB treatment
arm group label: 11C-acetate PET
arm group type: Experimental
description: 11C-acetate and FDG PET/MRI and PET/CT will be performed.
intervention type: Radiation
intervention name: 11C-acetate ligand
arm group label: 11C-acetate PET
intervention type: Radiation
intervention name: FDG ligand
arm group label: 11C-acetate PET
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