<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/NCT02986815</url>
  </required_header>
  <id_info>
    <org_study_id>STU 052016-034</org_study_id>
    <nct_id>NCT02986815</nct_id>
  </id_info>
  <brief_title>[11C]Acetate PET in Patients With Glioma</brief_title>
  <official_title>[11C]Acetate PET in Patients With Glioma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      At each point that the patient will have [11C]-Acetate PET study, this will be compared with&#xD;
      standard clinical MR imaging. Abbreviations: XRT - radiation therapy; TMZ - temozolomide&#xD;
      (chemotherapy)&#xD;
&#xD;
      Quantitative Image Data Analysis: The [11C]-Acetate uptake in tumor sites from images will be&#xD;
      analyzed qualitatively by visual assessment, quantitatively using a standard uptake value&#xD;
      (SUV) in the tumor relative to the contralateral normal brain, and the parameters obtained by&#xD;
      compartmental modeling of dynamic data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. [11C]Acetate Administration [11C]Acetate will be administered in the Clinical PET Facility&#xD;
      located on the 2nd floor of the Clements Imaging Building at UT Southwestern. Upon arrival,&#xD;
      the patient will have an opportunity to have questions answered regarding the procedure. The&#xD;
      patient will have one intravenous line placed prior to [11C]Acetate administration. The&#xD;
      patient will receive the low-dose CT portion of a PET/CT scan, after which [11C]Acetate will&#xD;
      be administered intravenously over approximately 1 min at a dose of 0.3 mCi/kg (maximum 30&#xD;
      mCi) and followed by a saline flush. The injection and imaging procedure will be terminated&#xD;
      in any patient who exhibits anaphylaxis, significant dyspnea or chest pain. The administering&#xD;
      physician will stay with the patient for at least 15 min after injection and will remain in&#xD;
      the Clinical PET Facility through the duration of the imaging procedure. All adverse events&#xD;
      occurring post [11C]Acetate infusion will be recorded within a 24-hour period. The adverse&#xD;
      events to be specifically monitored during the infusion include localized discomfort at the&#xD;
      IV injection site, pain, respiratory difficulties, flushing, dizziness, pruritus/rash, and&#xD;
      any other symptoms that could be secondary to an anaphylactic reaction. The subject will be&#xD;
      instructed to report any subjective symptoms or sensory changes noted.&#xD;
&#xD;
      Patients will be imaged on a Siemens Biograph 64 slice PET CT scanner. After placing the&#xD;
      patient on the scanner and securing the head in a head restraint, a low dose CT of the brain&#xD;
      will be acquired. Images with 3 mm slice thickness and spaced at 1.5 mm intervals will be&#xD;
      reconstructed in a 300 mm field of view. The purpose of the CT is for image localization and&#xD;
      attenuation correction and it is not considered to be a diagnostic quality CT. Following the&#xD;
      completion of the CT, the [11C]Acetate will be administered as described in Section VI.F.3.b.&#xD;
&#xD;
      A dynamic PET image will be acquired in 3D list mode for a total of 30 minutes. From the list&#xD;
      mode data a flow image series will be constructed as follows:&#xD;
&#xD;
        -  12 frames x 10 seconds each (out to 2 minutes post-injection)&#xD;
&#xD;
        -  then 6 frames x 30 seconds each&#xD;
&#xD;
        -  then 1 frame x 60 seconds each&#xD;
&#xD;
      A second series will be -reconstructed to demonstrate dynamic brain regional metabolism as&#xD;
      follows:&#xD;
&#xD;
        -  12 frames x 10 seconds each (out to 2 minutes post-injection)&#xD;
&#xD;
        -  then 8 frames x 30 seconds each (from 2 to 6 minutes)&#xD;
&#xD;
        -  then 4 frames x 60 seconds each (from 6 to 10 minutes)&#xD;
&#xD;
        -  then 2 frames of 300 seconds each (from 10 to 20 minutes)&#xD;
&#xD;
        -  then 1 frame of 600 seconds (from 20 to 30 minutes) Reconstructions will be performed&#xD;
           with a 128 x 128 image matrix using 3D OSEM (4 iterations, 21 subsets) and a 3 mm&#xD;
           Gaussian filter.&#xD;
&#xD;
           3. Study Procedures and Schedule of Events:&#xD;
&#xD;
             1. Initial visits prior to [11C]Acetate PET/CT:&#xD;
&#xD;
                Patients who are identified as potential candidates for the study will be&#xD;
                approached to explain the study and to obtain their written informed consent to be&#xD;
                enrolled in the protocol. The following additional patient data will be obtained:&#xD;
                histologic diagnosis (if a surgical procedure has been carried out), IDH mutational&#xD;
                status, age at radiologic diagnosis, weight, full medical and neurological history&#xD;
                and physical exam. Correlative imaging will be performed using MR brain, with and&#xD;
                without gadolinium, within 14 days prior to enrollment. In addition, when&#xD;
                available, 2-hydroxyglutarate (2HG) MR spectroscopy will be available for review&#xD;
                and determination of 2HG concentration. For patients referred from outside UTSW and&#xD;
                Parkland hospital, patient records and imaging will be reviewed to determine&#xD;
                eligibility for the study and to obtain baseline comparative imaging scans.&#xD;
&#xD;
             2. Day of baseline and follow up [11C]Acetate scans:&#xD;
&#xD;
                [11C]Acetate PET/CT scan performed at baseline and at the time of clinical follow&#xD;
                up; 3 months for grade 2 glioma patients on standard follow up, 2-3 months after&#xD;
                treatment for patients being imaged pre- and post-treatment. The patient will be&#xD;
                positioned supine in the PET/CT scanner for a dynamic scan over the brain. Patients&#xD;
                will have two intravenous lines placed, one in each arm. [11C]Acetate PET/CT will&#xD;
                be performed using the standard dose of 0.3 mCi/kg up to a maximum of 30mCi for&#xD;
                [11C]Acetate. A single imaging field over the brain will be imaged dynamically for&#xD;
                30 min following the start of a 1-min intravenous infusion of [11C]Acetate, as&#xD;
                described in Section VI.F.2.&#xD;
&#xD;
                4. General Concomitant Medication and Supportive Care Guidelines Any adverse&#xD;
                effects, related or non-related to the injection of [11C]Acetate, will be treated&#xD;
                as clinically indicated with no study-related restrictions.&#xD;
&#xD;
                5. Duration of Therapy and Follow-up: This is an observational study and patients&#xD;
                will remain on study for the duration of their clinical follow up, as determined by&#xD;
                their treating physician. [11C]Acetate PET scan timing will be determined based on&#xD;
                their individual clinical course.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">January 24, 2017</start_date>
  <completion_date type="Actual">May 5, 2020</completion_date>
  <primary_completion_date type="Actual">May 5, 2020</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>Visual differences from normal brain in patients with grades 2, 3 or 4 gliomas</measure>
    <time_frame>Every 3 months for 24 months</time_frame>
    <description>Visual assessment and SUV with standard clinical MR imaging assessment.using T2/FLAIR and gadolinium enhancement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease in [11C]Acetate uptake following treatment of grade 2 glioma</measure>
    <time_frame>Every 3 months for 24 months</time_frame>
    <description>Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in [11C]-acetate uptake following treatment of grade 3 and 4 glioma</measure>
    <time_frame>Every 3 months for 24 months</time_frame>
    <description>Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in [11C]-acetate uptake following treatment at time of progression in grade 3 and 4 gliomas</measure>
    <time_frame>Every 3 months for 24 months</time_frame>
    <description>Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Glioma</condition>
  <arm_group>
    <arm_group_label>[11C]Acetate Brain Imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[11C]Acetate will be administered The patient will have one intravenous line placed prior to [11C]Acetate administration. The patient will receive the low-dose CT portion of a PET/CT scan, after which [11C]Acetate will be administered intravenously over approximately 1 min at a dose of 0.3 mCi/kg (maximum 30 mCi) and followed by a saline flush. The injection and imaging procedure will be terminated in any patient who exhibits anaphylaxis, significant dyspnea or chest pain. The administering physician will stay with the patient for at least 15 min after injection and will remain in the Clinical PET Facility through the duration of the imaging procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>[11C]Acetate Brain Imaging</intervention_name>
    <description>Patients will be imaged on a Siemens Biograph 64 slice PET CT scanner. After placing the patient on the scanner and securing the head in a head restraint, a low dose CT of the brain will be acquired. Images with 3 mm slice thickness and spaced at 1.5 mm intervals will be reconstructed in a 300 mm field of view. The purpose of the CT is for image localization and attenuation correction and it is not considered to be a diagnostic quality CT. Following the completion of the CT, the [11C]Acetate will be administered. A dynamic PET image will be acquired in 3D list mode for a total of 30 minutes.</description>
    <arm_group_label>[11C]Acetate Brain Imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age 18 and older, of any ethnic group&#xD;
&#xD;
          -  Spanish-speaking patients will be eligible&#xD;
&#xD;
          -  Histological diagnosis of glioma or&#xD;
&#xD;
          -  Brain MR imaging suggestive of a glioma or 2HG &gt; 2mM by MR spectroscopy in patients&#xD;
             who have not had a surgical procedure to establish the diagnosis.&#xD;
&#xD;
          -  Karnofsky Performance status &gt; 70%&#xD;
&#xD;
          -  Negative serum pregnancy test or child bearing potential terminated by surgery,&#xD;
             radiation, menopause or current use of two approved methods of birth control&#xD;
&#xD;
          -  Patient able and willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient or legal parent/guardian unable to provide informed consent&#xD;
&#xD;
          -  Psychiatric or addictive disorders that preclude obtaining informed consent&#xD;
&#xD;
          -  Karnofsky Performance status &lt; 70%&#xD;
&#xD;
          -  NYHA class III and IV congestive heart failure&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Women of childbearing potential who refuse a pregnancy test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2021</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>Glioma</mesh_term>
  </condition_browse>
  <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/NCT02986815
org study id: STU 052016-034
nct id: NCT02986815
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
At each point that the patient will have [11C]-Acetate PET study, this will be compared with
      standard clinical MR imaging. Abbreviations: XRT - radiation therapy; TMZ - temozolomide
      (chemotherapy)

      Quantitative Image Data Analysis: The [11C]-Acetate uptake in tumor sites from images will be
      analyzed qualitatively by visual assessment, quantitatively using a standard uptake value
      (SUV) in the tumor relative to the contralateral normal brain, and the parameters obtained by
      compartmental modeling of dynamic data.
1. [11C]Acetate Administration [11C]Acetate will be administered in the Clinical PET Facility
      located on the 2nd floor of the Clements Imaging Building at UT Southwestern. Upon arrival,
      the patient will have an opportunity to have questions answered regarding the procedure. The
      patient will have one intravenous line placed prior to [11C]Acetate administration. The
      patient will receive the low-dose CT portion of a PET/CT scan, after which [11C]Acetate will
      be administered intravenously over approximately 1 min at a dose of 0.3 mCi/kg (maximum 30
      mCi) and followed by a saline flush. The injection and imaging procedure will be terminated
      in any patient who exhibits anaphylaxis, significant dyspnea or chest pain. The administering
      physician will stay with the patient for at least 15 min after injection and will remain in
      the Clinical PET Facility through the duration of the imaging procedure. All adverse events
      occurring post [11C]Acetate infusion will be recorded within a 24-hour period. The adverse
      events to be specifically monitored during the infusion include localized discomfort at the
      IV injection site, pain, respiratory difficulties, flushing, dizziness, pruritus/rash, and
      any other symptoms that could be secondary to an anaphylactic reaction. The subject will be
      instructed to report any subjective symptoms or sensory changes noted.

      Patients will be imaged on a Siemens Biograph 64 slice PET CT scanner. After placing the
      patient on the scanner and securing the head in a head restraint, a low dose CT of the brain
      will be acquired. Images with 3 mm slice thickness and spaced at 1.5 mm intervals will be
      reconstructed in a 300 mm field of view. The purpose of the CT is for image localization and
      attenuation correction and it is not considered to be a diagnostic quality CT. Following the
      completion of the CT, the [11C]Acetate will be administered as described in Section VI.F.3.b.

      A dynamic PET image will be acquired in 3D list mode for a total of 30 minutes. From the list
      mode data a flow image series will be constructed as follows:

        -  12 frames x 10 seconds each (out to 2 minutes post-injection)

        -  then 6 frames x 30 seconds each

        -  then 1 frame x 60 seconds each

      A second series will be -reconstructed to demonstrate dynamic brain regional metabolism as
      follows:

        -  12 frames x 10 seconds each (out to 2 minutes post-injection)

        -  then 8 frames x 30 seconds each (from 2 to 6 minutes)

        -  then 4 frames x 60 seconds each (from 6 to 10 minutes)

        -  then 2 frames of 300 seconds each (from 10 to 20 minutes)

        -  then 1 frame of 600 seconds (from 20 to 30 minutes) Reconstructions will be performed
           with a 128 x 128 image matrix using 3D OSEM (4 iterations, 21 subsets) and a 3 mm
           Gaussian filter.

           3. Study Procedures and Schedule of Events:

             1. Initial visits prior to [11C]Acetate PET/CT:

                Patients who are identified as potential candidates for the study will be
                approached to explain the study and to obtain their written informed consent to be
                enrolled in the protocol. The following additional patient data will be obtained:
                histologic diagnosis (if a surgical procedure has been carried out), IDH mutational
                status, age at radiologic diagnosis, weight, full medical and neurological history
                and physical exam. Correlative imaging will be performed using MR brain, with and
                without gadolinium, within 14 days prior to enrollment. In addition, when
                available, 2-hydroxyglutarate (2HG) MR spectroscopy will be available for review
                and determination of 2HG concentration. For patients referred from outside UTSW and
                Parkland hospital, patient records and imaging will be reviewed to determine
                eligibility for the study and to obtain baseline comparative imaging scans.

             2. Day of baseline and follow up [11C]Acetate scans:

                [11C]Acetate PET/CT scan performed at baseline and at the time of clinical follow
                up; 3 months for grade 2 glioma patients on standard follow up, 2-3 months after
                treatment for patients being imaged pre- and post-treatment. The patient will be
                positioned supine in the PET/CT scanner for a dynamic scan over the brain. Patients
                will have two intravenous lines placed, one in each arm. [11C]Acetate PET/CT will
                be performed using the standard dose of 0.3 mCi/kg up to a maximum of 30mCi for
                [11C]Acetate. A single imaging field over the brain will be imaged dynamically for
                30 min following the start of a 1-min intravenous infusion of [11C]Acetate, as
                described in Section VI.F.2.

                4. General Concomitant Medication and Supportive Care Guidelines Any adverse
                effects, related or non-related to the injection of [11C]Acetate, will be treated
                as clinically indicated with no study-related restrictions.

                5. Duration of Therapy and Follow-up: This is an observational study and patients
                will remain on study for the duration of their clinical follow up, as determined by
                their treating physician. [11C]Acetate PET scan timing will be determined based on
                their individual clinical course.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Visual differences from normal brain in patients with grades 2, 3 or 4 gliomas
time frame: Every 3 months for 24 months
description: Visual assessment and SUV with standard clinical MR imaging assessment.using T2/FLAIR and gadolinium enhancement.
measure: Decrease in [11C]Acetate uptake following treatment of grade 2 glioma
time frame: Every 3 months for 24 months
description: Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate
measure: Decrease in [11C]-acetate uptake following treatment of grade 3 and 4 glioma
time frame: Every 3 months for 24 months
description: Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate.
measure: Change in [11C]-acetate uptake following treatment at time of progression in grade 3 and 4 gliomas
time frame: Every 3 months for 24 months
description: Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate
arm group label: [11C]Acetate Brain Imaging
arm group type: Experimental
description: [11C]Acetate will be administered The patient will have one intravenous line placed prior to [11C]Acetate administration. The patient will receive the low-dose CT portion of a PET/CT scan, after which [11C]Acetate will be administered intravenously over approximately 1 min at a dose of 0.3 mCi/kg (maximum 30 mCi) and followed by a saline flush. The injection and imaging procedure will be terminated in any patient who exhibits anaphylaxis, significant dyspnea or chest pain. The administering physician will stay with the patient for at least 15 min after injection and will remain in the Clinical PET Facility through the duration of the imaging procedure.
intervention type: Other
intervention name: [11C]Acetate Brain Imaging
description: Patients will be imaged on a Siemens Biograph 64 slice PET CT scanner. After placing the patient on the scanner and securing the head in a head restraint, a low dose CT of the brain will be acquired. Images with 3 mm slice thickness and spaced at 1.5 mm intervals will be reconstructed in a 300 mm field of view. The purpose of the CT is for image localization and attenuation correction and it is not considered to be a diagnostic quality CT. Following the completion of the CT, the [11C]Acetate will be administered. A dynamic PET image will be acquired in 3D list mode for a total of 30 minutes.
arm group label: [11C]Acetate Brain Imaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glioma
sharing ipd: No