<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/NCT03001349</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0030</org_study_id>
    <secondary_id>NCI-2018-01894</secondary_id>
    <secondary_id>2016-0030</secondary_id>
    <nct_id>NCT03001349</nct_id>
  </id_info>
  <brief_title>68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors</brief_title>
  <official_title>An Expanded Access Imaging of Neuroendocrine Tumors Using 68Ga-DOTA-TOC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well gallium Ga 68-edotreotide (68Ga-DOTA-TOC) positron emission&#xD;
      tomography (PET)/computer tomography (CT) works in imaging participants with neuroendocrine&#xD;
      tumors. 68Ga-DOTA-TOC is used as a tracer chemical during PET/CT scans. Diagnostic&#xD;
      procedures, such as 68Ga-DOTA-TOC PET/CT, may help find and diagnose neuroendocrine tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To substitute 68Ga-DOTATOC for 111In-pentetreotide on an expanded access basis, in tumor&#xD;
      imaging for study subjects, where the care provider believes that somatostatin imaging is&#xD;
      clinically indicated, until such time as 68Ga-DOTATOC becomes commercially available.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To gain experience in the utility of 68Ga-DOTATOC in the management of neuroendocrine&#xD;
      tumors at The University of Texas M.D. Anderson Cancer Center (MDACC).&#xD;
&#xD;
      II. To acquire proficiency in generating 68Ga-DOTATOC for human use at MDACC.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants&#xD;
      undergo PET/CT scan over 60 minutes.&#xD;
&#xD;
      After completion of study, participants are followed up at 24 hours or within 72 hours, and&#xD;
      at 30 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Per PI Request&#xD;
  </why_stopped>
  <start_date type="Actual">May 16, 2017</start_date>
  <completion_date type="Actual">February 5, 2021</completion_date>
  <primary_completion_date type="Actual">February 5, 2021</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <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>Incidence of adverse events</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>As measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 4. Traceable toxicity/safety data will be assessed. Adverse events and vital signs will be monitored and described with descriptive statistics.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Meningioma</condition>
  <condition>Metastatic Well Differentiated Neuroendocrine Neoplasm</condition>
  <condition>Multiple Endocrine Neoplasia Type 1</condition>
  <condition>Neuroendocrine Neoplasm</condition>
  <condition>Somatostatin Positive Neoplastic Cells Present</condition>
  <condition>Von Hippel-Lindau Syndrome</condition>
  <arm_group>
    <arm_group_label>Diagnostic (gallium Ga 68-edotreotide, PET/CT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants undergo PET/CT scan over 60 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed Tomography</intervention_name>
    <description>Undergo PET/CT</description>
    <arm_group_label>Diagnostic (gallium Ga 68-edotreotide, PET/CT)</arm_group_label>
    <other_name>CAT</other_name>
    <other_name>CAT Scan</other_name>
    <other_name>Computerized Axial Tomography</other_name>
    <other_name>computerized tomography</other_name>
    <other_name>CT</other_name>
    <other_name>CT SCAN</other_name>
    <other_name>tomography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gallium Ga 68-Edotreotide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (gallium Ga 68-edotreotide, PET/CT)</arm_group_label>
    <other_name>68Ga-DOTA-d-Phe1-Tyr3-octreotide</other_name>
    <other_name>68Ga-DOTA-TOC</other_name>
    <other_name>EDOTREOTIDE GALLIUM GA-68</other_name>
    <other_name>Ga-68 DOTA0-Tyr3-octreotide</other_name>
    <other_name>Ga-68 DOTATOC</other_name>
    <other_name>Ga-68-DOTA-TOC</other_name>
    <other_name>Ga-68-DOTA-Tyr(3)-octreotide</other_name>
    <other_name>Gallium Ga 68-DOTATOC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Undergo PET/CT</description>
    <arm_group_label>Diagnostic (gallium Ga 68-edotreotide, PET/CT)</arm_group_label>
    <other_name>Medical Imaging, Positron Emission Tomography</other_name>
    <other_name>PET</other_name>
    <other_name>PET Scan</other_name>
    <other_name>Positron Emission Tomography Scan</other_name>
    <other_name>Positron-Emission Tomography</other_name>
    <other_name>proton magnetic resonance spectroscopic imaging</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability of the subject, or the legally authorized representative (LAR), if the patient&#xD;
             is deemed by the treating physician to be cognitively impaired or questionably&#xD;
             impaired in such a way that the ability of the patient to give informed consent is&#xD;
             questionable, to understand, and the willingness to sign, a written informed consent&#xD;
&#xD;
          -  All participants must meet one of the following:&#xD;
&#xD;
               -  Patients diagnosed or suspected to have neuroendocrine tumors (NET), who require&#xD;
                  111In-pentetreotide imaging for clinical indications&#xD;
&#xD;
               -  Subjects with a high risk of NET because of familial predisposition, and also&#xD;
                  have clinical findings which require radiolabeled somatostatin imaging&#xD;
&#xD;
               -  Other somatostatin-positive tumors for which 111In-pentetreotide has been used&#xD;
                  successfully, such as adult meningiomas&#xD;
&#xD;
               -  Patients with suspected neuroendocrine tumor, unknown primary NET, metastatic&#xD;
                  NET, or other tumors, such as meningiomas, in whom the primary physician&#xD;
                  considers somatostatin imaging to be clinically indicated&#xD;
&#xD;
               -  Other NET subjects, whether asymptomatic or symptomatic, sporadic or familial,&#xD;
                  such as Von Hippel-Lindau syndrome (VHL) and multiple endocrine neoplasia type 1&#xD;
                  (MEN1), will also be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in&#xD;
             pregnancy are not known; exceptions may be granted only if the expected risk outweighs&#xD;
             the benefit, in the clinical opinion of the attending physician. Pregnancy testing&#xD;
             will follow MD Anderson procedure for diagnostic reagents. Self-reporting is used to&#xD;
             assess pregnancy status. If the subject is unsure about her status, a urine or serum&#xD;
             pregnancy test will be performed before inclusion&#xD;
&#xD;
          -  Lactating women are excluded if patient is unwilling to suspend lactation for at least&#xD;
             one day following the administration of 68Ga-DOTATOC to the mother, because of the&#xD;
             unknown but potential risk for adverse events in nursing infants secondary to&#xD;
             administration of the radionuclide to a lactating woman&#xD;
&#xD;
          -  Subjects with known contraindications to the use of 111In-pentetreotide&#xD;
&#xD;
          -  Known severe allergy or hypersensitivity to oral contrast precludes administration of&#xD;
             oral contrast only&#xD;
&#xD;
          -  Patients with a body weight of 400 pounds or more, or a body mass index (BMI) which&#xD;
             precludes their entry into the bore of the PET/CT scanner, because of the resulting&#xD;
             probable compromise in image quality with CT, PET/CT and magnetic resonance imaging&#xD;
             (MRI)&#xD;
&#xD;
          -  Any additional medical condition, serious intercurrent illness, or other extenuating&#xD;
             circumstance that, in the opinion of the investigator may significantly interfere with&#xD;
             study compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Homer A Macapinlac, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 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>Neoplasms</mesh_term>
    <mesh_term>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Meningioma</mesh_term>
    <mesh_term>Endocrine Gland Neoplasms</mesh_term>
    <mesh_term>Multiple Endocrine Neoplasia</mesh_term>
    <mesh_term>Multiple Endocrine Neoplasia Type 1</mesh_term>
    <mesh_term>Von Hippel-Lindau Disease</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/NCT03001349
org study id: 2016-0030
secondary id: NCI-2018-01894
secondary id: 2016-0030
nct id: NCT03001349
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This trial studies how well gallium Ga 68-edotreotide (68Ga-DOTA-TOC) positron emission
      tomography (PET)/computer tomography (CT) works in imaging participants with neuroendocrine
      tumors. 68Ga-DOTA-TOC is used as a tracer chemical during PET/CT scans. Diagnostic
      procedures, such as 68Ga-DOTA-TOC PET/CT, may help find and diagnose neuroendocrine tumors.
PRIMARY OBJECTIVES:

      I. To substitute 68Ga-DOTATOC for 111In-pentetreotide on an expanded access basis, in tumor
      imaging for study subjects, where the care provider believes that somatostatin imaging is
      clinically indicated, until such time as 68Ga-DOTATOC becomes commercially available.

      SECONDARY OBJECTIVES:

      I. To gain experience in the utility of 68Ga-DOTATOC in the management of neuroendocrine
      tumors at The University of Texas M.D. Anderson Cancer Center (MDACC).

      II. To acquire proficiency in generating 68Ga-DOTATOC for human use at MDACC.

      OUTLINE:

      Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants
      undergo PET/CT scan over 60 minutes.

      After completion of study, participants are followed up at 24 hours or within 72 hours, and
      at 30 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Incidence of adverse events
time frame: Up to 30 days
description: As measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 4. Traceable toxicity/safety data will be assessed. Adverse events and vital signs will be monitored and described with descriptive statistics.
arm group label: Diagnostic (gallium Ga 68-edotreotide, PET/CT)
arm group type: Experimental
description: Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants undergo PET/CT scan over 60 minutes.
intervention type: Procedure
intervention name: Computed Tomography
description: Undergo PET/CT
arm group label: Diagnostic (gallium Ga 68-edotreotide, PET/CT)
other name: CAT
other name: CAT Scan
other name: Computerized Axial Tomography
other name: computerized tomography
other name: CT
other name: CT SCAN
other name: tomography
intervention type: Drug
intervention name: Gallium Ga 68-Edotreotide
description: Given IV
arm group label: Diagnostic (gallium Ga 68-edotreotide, PET/CT)
other name: 68Ga-DOTA-d-Phe1-Tyr3-octreotide
other name: 68Ga-DOTA-TOC
other name: EDOTREOTIDE GALLIUM GA-68
other name: Ga-68 DOTA0-Tyr3-octreotide
other name: Ga-68 DOTATOC
other name: Ga-68-DOTA-TOC
other name: Ga-68-DOTA-Tyr(3)-octreotide
other name: Gallium Ga 68-DOTATOC
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Undergo PET/CT
arm group label: Diagnostic (gallium Ga 68-edotreotide, PET/CT)
other name: Medical Imaging, Positron Emission Tomography
other name: PET
other name: PET Scan
other name: Positron Emission Tomography Scan
other name: Positron-Emission Tomography
other name: proton magnetic resonance spectroscopic imaging
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Homer A Macapinlac, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Neuroendocrine Tumors
mesh term: Meningioma
mesh term: Endocrine Gland Neoplasms
mesh term: Multiple Endocrine Neoplasia
mesh term: Multiple Endocrine Neoplasia Type 1
mesh term: Von Hippel-Lindau Disease
mesh term: Octreotide
mesh term: Edotreotide