<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/NCT02194452</url>
  </required_header>
  <id_info>
    <org_study_id>201302711</org_study_id>
    <secondary_id>P30CA086862</secondary_id>
    <nct_id>NCT02194452</nct_id>
  </id_info>
  <brief_title>Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors</brief_title>
  <official_title>Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sue O'Dorisio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ride for Kids</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission&#xD;
      tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients.&#xD;
      Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and&#xD;
      diagnose brain tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if 68Ga-DOTATOC (gallium Ga 68-edotreotide) PET when combined with magnetic&#xD;
      resonance imaging (MRI) will differentiate embryonal tumors such as medulloblastoma and&#xD;
      supratentorial primitive neuroectodermal tumor (PNET) from the low and high grade gliomas.&#xD;
&#xD;
      II. To determine if 68Ga-DOTATOC PET will aid in the identification of residual tumor post&#xD;
      operatively in those patients who were 68Ga-DOTATOC PET positive prior to surgery.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo gallium Ga 68-edotreotide PET/CT at baseline and 1-30 days after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide</measure>
    <time_frame>Baseline up to 30 days</time_frame>
    <description>The endpoint is a binary outcome (+ or -) of SUV uptake (after gallium Ga 68-edotreotide) and a binary outcome confirmed at biopsy (+ or -).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy</measure>
    <time_frame>Up to 30 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Acoustic Schwannoma</condition>
  <condition>Adult Anaplastic Astrocytoma</condition>
  <condition>Adult Anaplastic Ependymoma</condition>
  <condition>Adult Anaplastic Meningioma</condition>
  <condition>Adult Anaplastic Oligodendroglioma</condition>
  <condition>Adult Brain Stem Glioma</condition>
  <condition>Adult Choroid Plexus Tumor</condition>
  <condition>Adult Craniopharyngioma</condition>
  <condition>Adult Diffuse Astrocytoma</condition>
  <condition>Adult Ependymoblastoma</condition>
  <condition>Adult Ependymoma</condition>
  <condition>Adult Giant Cell Glioblastoma</condition>
  <condition>Adult Glioblastoma</condition>
  <condition>Adult Gliosarcoma</condition>
  <condition>Adult Grade I Meningioma</condition>
  <condition>Adult Grade II Meningioma</condition>
  <condition>Adult Medulloblastoma</condition>
  <condition>Adult Meningeal Hemangiopericytoma</condition>
  <condition>Adult Mixed Glioma</condition>
  <condition>Adult Myxopapillary Ependymoma</condition>
  <condition>Adult Oligodendroglioma</condition>
  <condition>Adult Papillary Meningioma</condition>
  <condition>Adult Pilocytic Astrocytoma</condition>
  <condition>Adult Pineal Gland Astrocytoma</condition>
  <condition>Adult Pineoblastoma</condition>
  <condition>Adult Pineocytoma</condition>
  <condition>Adult Subependymal Giant Cell Astrocytoma</condition>
  <condition>Adult Subependymoma</condition>
  <condition>Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)</condition>
  <condition>Childhood Choroid Plexus Tumor</condition>
  <condition>Childhood Craniopharyngioma</condition>
  <condition>Childhood Ependymoblastoma</condition>
  <condition>Childhood Grade I Meningioma</condition>
  <condition>Childhood Grade II Meningioma</condition>
  <condition>Childhood Grade III Meningioma</condition>
  <condition>Childhood High-grade Cerebellar Astrocytoma</condition>
  <condition>Childhood High-grade Cerebral Astrocytoma</condition>
  <condition>Childhood Infratentorial Ependymoma</condition>
  <condition>Childhood Low-grade Cerebellar Astrocytoma</condition>
  <condition>Childhood Low-grade Cerebral Astrocytoma</condition>
  <condition>Childhood Medulloepithelioma</condition>
  <condition>Childhood Supratentorial Ependymoma</condition>
  <condition>Meningeal Melanocytoma</condition>
  <condition>Newly Diagnosed Childhood Ependymoma</condition>
  <condition>Recurrent Adult Brain Tumor</condition>
  <condition>Recurrent Childhood Anaplastic Astrocytoma</condition>
  <condition>Recurrent Childhood Anaplastic Oligoastrocytoma</condition>
  <condition>Recurrent Childhood Anaplastic Oligodendroglioma</condition>
  <condition>Recurrent Childhood Brain Stem Glioma</condition>
  <condition>Recurrent Childhood Cerebellar Astrocytoma</condition>
  <condition>Recurrent Childhood Cerebral Astrocytoma</condition>
  <condition>Recurrent Childhood Diffuse Astrocytoma</condition>
  <condition>Recurrent Childhood Ependymoma</condition>
  <condition>Recurrent Childhood Fibrillary Astrocytoma</condition>
  <condition>Recurrent Childhood Gemistocytic Astrocytoma</condition>
  <condition>Recurrent Childhood Giant Cell Glioblastoma</condition>
  <condition>Recurrent Childhood Glioblastoma</condition>
  <condition>Recurrent Childhood Gliomatosis Cerebri</condition>
  <condition>Recurrent Childhood Gliosarcoma</condition>
  <condition>Recurrent Childhood Medulloblastoma</condition>
  <condition>Recurrent Childhood Oligoastrocytoma</condition>
  <condition>Recurrent Childhood Oligodendroglioma</condition>
  <condition>Recurrent Childhood Pilocytic Astrocytoma</condition>
  <condition>Recurrent Childhood Pilomyxoid Astrocytoma</condition>
  <condition>Recurrent Childhood Pineoblastoma</condition>
  <condition>Recurrent Childhood Pleomorphic Xanthoastrocytoma</condition>
  <condition>Recurrent Childhood Protoplasmic Astrocytoma</condition>
  <condition>Recurrent Childhood Subependymal Giant Cell Astrocytoma</condition>
  <condition>Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor</condition>
  <condition>Recurrent Childhood Visual Pathway and Hypothalamic Glioma</condition>
  <condition>Recurrent Childhood Visual Pathway Glioma</condition>
  <condition>Untreated Childhood Anaplastic Astrocytoma</condition>
  <condition>Untreated Childhood Anaplastic Oligodendroglioma</condition>
  <condition>Untreated Childhood Brain Stem Glioma</condition>
  <condition>Untreated Childhood Cerebellar Astrocytoma</condition>
  <condition>Untreated Childhood Cerebral Astrocytoma</condition>
  <condition>Untreated Childhood Diffuse Astrocytoma</condition>
  <condition>Untreated Childhood Fibrillary Astrocytoma</condition>
  <condition>Untreated Childhood Gemistocytic Astrocytoma</condition>
  <condition>Untreated Childhood Giant Cell Glioblastoma</condition>
  <condition>Untreated Childhood Glioblastoma</condition>
  <condition>Untreated Childhood Gliomatosis Cerebri</condition>
  <condition>Untreated Childhood Gliosarcoma</condition>
  <condition>Untreated Childhood Medulloblastoma</condition>
  <condition>Untreated Childhood Oligoastrocytoma</condition>
  <condition>Untreated Childhood Oligodendroglioma</condition>
  <condition>Untreated Childhood Pilocytic Astrocytoma</condition>
  <condition>Untreated Childhood Pilomyxoid Astrocytoma</condition>
  <condition>Untreated Childhood Pineoblastoma</condition>
  <condition>Untreated Childhood Pleomorphic Xanthoastrocytoma</condition>
  <condition>Untreated Childhood Protoplasmic Astrocytoma</condition>
  <condition>Untreated Childhood Subependymal Giant Cell Astrocytoma</condition>
  <condition>Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor</condition>
  <condition>Untreated Childhood Visual Pathway and Hypothalamic Glioma</condition>
  <condition>Untreated Childhood Visual Pathway Glioma</condition>
  <arm_group>
    <arm_group_label>Diagnostic (gallium Ga 68-edotreotide PET/CT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo gallium Ga 68-edotreotide PET/CT at baseline and 1-30 days after surgery.&#xD;
Interventions: gallium Ga 68-edotreotide, positron emission tomography, computed tomography, laboratory biomarker analysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>gallium Ga 68-edotreotide</intervention_name>
    <description>Undergo gallium Ga 68-edotreotide PET/CT</description>
    <arm_group_label>Diagnostic (gallium Ga 68-edotreotide PET/CT)</arm_group_label>
    <other_name>Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>positron emission tomography</intervention_name>
    <description>Undergo gallium Ga 68-edotreotide PET/CT</description>
    <arm_group_label>Diagnostic (gallium Ga 68-edotreotide PET/CT)</arm_group_label>
    <other_name>FDG-PET, PET, PET scan, tomography, emission computed</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>computed tomography</intervention_name>
    <description>Undergo gallium Ga 68-edotreotide PET/CT</description>
    <arm_group_label>Diagnostic (gallium Ga 68-edotreotide PET/CT)</arm_group_label>
    <other_name>tomography, computed</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Diagnostic (gallium Ga 68-edotreotide PET/CT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting with brain tumors will be eligible for this study&#xD;
&#xD;
          -  Eligible subjects must be able and willing to undergo the procedures of the study&#xD;
&#xD;
          -  Electronic version of pre-surgery MRI must be available for co-registration purposes&#xD;
&#xD;
          -  Fresh frozen tumor, and/or paraffin block of biopsy or resected tumor is recommended,&#xD;
             but not required to determine expression of somatostatin receptors in tumor by&#xD;
             immunohistochemistry and/or quantitative polymerase chain reaction (qPCR)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal&#xD;
             fragments or foreign objects in the eyes, skin of body that would preclude obtaining&#xD;
             an MRI as part of the initial study evaluation&#xD;
&#xD;
          -  Inability to complete the needed investigational and standard-of-care imaging&#xD;
             examinations due to other reasons&#xD;
&#xD;
          -  Presence of any additional medical condition such as inter-current illness, or other&#xD;
             extenuating circumstance that, in the opinion of the investigator, may significantly&#xD;
             interfere with study compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>M. Sue O'Dorisio, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>April 27, 2017</last_update_submitted>
  <last_update_submitted_qc>April 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Sue O'Dorisio</investigator_full_name>
    <investigator_title>Professor Pediatrics-HEM-Oncology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Glioma</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Astrocytoma</mesh_term>
    <mesh_term>Meningioma</mesh_term>
    <mesh_term>Ependymoma</mesh_term>
    <mesh_term>Gliosarcoma</mesh_term>
    <mesh_term>Medulloblastoma</mesh_term>
    <mesh_term>Oligodendroglioma</mesh_term>
    <mesh_term>Neuroectodermal Tumors</mesh_term>
    <mesh_term>Neuroectodermal Tumors, Primitive</mesh_term>
    <mesh_term>Neurilemmoma</mesh_term>
    <mesh_term>Craniopharyngioma</mesh_term>
    <mesh_term>Adamantinoma</mesh_term>
    <mesh_term>Choroid Plexus Neoplasms</mesh_term>
    <mesh_term>Pinealoma</mesh_term>
    <mesh_term>Optic Nerve Glioma</mesh_term>
    <mesh_term>Hemangiopericytoma</mesh_term>
    <mesh_term>Solitary Fibrous Tumors</mesh_term>
    <mesh_term>Glioma, Subependymal</mesh_term>
    <mesh_term>Sarcoma, Ewing</mesh_term>
    <mesh_term>Neuroectodermal Tumors, Primitive, Peripheral</mesh_term>
    <mesh_term>Neoplasms, Neuroepithelial</mesh_term>
    <mesh_term>Neuroma, Acoustic</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Octreotide</mesh_term>
    <mesh_term>Edotreotide</mesh_term>
  </intervention_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/NCT02194452
org study id: 201302711
secondary id: P30CA086862
nct id: NCT02194452
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission
      tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients.
      Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and
      diagnose brain tumors.
PRIMARY OBJECTIVES:

      I. To determine if 68Ga-DOTATOC (gallium Ga 68-edotreotide) PET when combined with magnetic
      resonance imaging (MRI) will differentiate embryonal tumors such as medulloblastoma and
      supratentorial primitive neuroectodermal tumor (PNET) from the low and high grade gliomas.

      II. To determine if 68Ga-DOTATOC PET will aid in the identification of residual tumor post
      operatively in those patients who were 68Ga-DOTATOC PET positive prior to surgery.

      OUTLINE:

      Patients undergo gallium Ga 68-edotreotide PET/CT at baseline and 1-30 days after surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide
time frame: Baseline up to 30 days
description: The endpoint is a binary outcome (+ or -) of SUV uptake (after gallium Ga 68-edotreotide) and a binary outcome confirmed at biopsy (+ or -).
measure: Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy
time frame: Up to 30 days
arm group label: Diagnostic (gallium Ga 68-edotreotide PET/CT)
arm group type: Experimental
description: Patients undergo gallium Ga 68-edotreotide PET/CT at baseline and 1-30 days after surgery.
Interventions: gallium Ga 68-edotreotide, positron emission tomography, computed tomography, laboratory biomarker analysis
intervention type: Radiation
intervention name: gallium Ga 68-edotreotide
description: Undergo gallium Ga 68-edotreotide PET/CT
arm group label: Diagnostic (gallium Ga 68-edotreotide PET/CT)
other name: Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC
intervention type: Procedure
intervention name: positron emission tomography
description: Undergo gallium Ga 68-edotreotide PET/CT
arm group label: Diagnostic (gallium Ga 68-edotreotide PET/CT)
other name: FDG-PET, PET, PET scan, tomography, emission computed
intervention type: Procedure
intervention name: computed tomography
description: Undergo gallium Ga 68-edotreotide PET/CT
arm group label: Diagnostic (gallium Ga 68-edotreotide PET/CT)
other name: tomography, computed
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Diagnostic (gallium Ga 68-edotreotide PET/CT)
criteria: 
gender: All
minimum age: 6 Months
maximum age: 29 Years
healthy volunteers: No
last name: M. Sue O'Dorisio, MD, PhD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Sue O'Dorisio
investigator title: Professor Pediatrics-HEM-Oncology
mesh term: Neoplasms
mesh term: Glioblastoma
mesh term: Glioma
mesh term: Brain Neoplasms
mesh term: Astrocytoma
mesh term: Meningioma
mesh term: Ependymoma
mesh term: Gliosarcoma
mesh term: Medulloblastoma
mesh term: Oligodendroglioma
mesh term: Neuroectodermal Tumors
mesh term: Neuroectodermal Tumors, Primitive
mesh term: Neurilemmoma
mesh term: Craniopharyngioma
mesh term: Adamantinoma
mesh term: Choroid Plexus Neoplasms
mesh term: Pinealoma
mesh term: Optic Nerve Glioma
mesh term: Hemangiopericytoma
mesh term: Solitary Fibrous Tumors
mesh term: Glioma, Subependymal
mesh term: Sarcoma, Ewing
mesh term: Neuroectodermal Tumors, Primitive, Peripheral
mesh term: Neoplasms, Neuroepithelial
mesh term: Neuroma, Acoustic
mesh term: Recurrence
mesh term: Octreotide
mesh term: Edotreotide