<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/NCT04491851</url>
  </required_header>
  <id_info>
    <org_study_id>ANTANET</org_study_id>
    <nct_id>NCT04491851</nct_id>
  </id_info>
  <brief_title>Impact of Peptides and Chelators on Somatostatin Receptor Antagonists</brief_title>
  <official_title>A Prospective Study to Evaluate the Impact of Different Peptides and Chelators on the Diagnostic Performance of PET/CT Using Gallium-68 Labeled Somatostatin Receptor Antagonists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Somatostatin receptor antagonists are emerging agents in molecular imaging of neuroendocrine&#xD;
      tumors. There're two main antagonist peptides, namely JR11 and LM3, which can be coupled with&#xD;
      different chelators, DOTA and NODAGA. Previous studies by our and other groups have revealed&#xD;
      the different diagnostic performances of these tracers. However, head-to-head comparison data&#xD;
      is still missing. In this study, we aim to evaluate the diagnostic performance of four&#xD;
      different antagonists, that is, NODAGA-LM3, DOTA-LM3, and NODAGA-JR11, all labeled with&#xD;
      gallium-68.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomly assigned into two arms:&#xD;
&#xD;
      Arm A : 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 Arm B : 68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11&#xD;
&#xD;
      In each arm, patients will undergo PET/CT using assigned tracers. Lesion detection, lesion&#xD;
      SUV, and the tumor-to-background ratio will be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will be randomly assigned into four arms:&#xD;
Arm A : 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 Arm B : 68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The details of patient groups will be sealed in sequentially numbered, opaque, sealed envelopes generated by Xuezhu Wang from the nuclear medicine department, Peking Union Medical College Hospital, who will not participate in other parts of the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Lesion numbers</measure>
    <time_frame>At 1-hours post-injection</time_frame>
    <description>Determination of lesion numbers of 68Ga-NODAGA-LM3, 68Ga-DOTA-LM3, and 68Ga-NODAGA-JR11 scan.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standard uptake value (SUV)</measure>
    <time_frame>At 1-hours post-injection</time_frame>
    <description>Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-LM3, 68Ga-DOTA-LM3, and 68Ga-NODAGA-JR11 scan.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <arm_group>
    <arm_group_label>LM3 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-DOTA-LM3 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NODAGA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-NODAGA-JR11 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 PET/CT</intervention_name>
    <description>Patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-DOTA-LM3 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.</description>
    <arm_group_label>LM3 group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11 PET/CT</intervention_name>
    <description>Patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-NODAGA-JR11 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.</description>
    <arm_group_label>NODAGA group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
          -  Patients of either gender, aged ≥ 18 years.&#xD;
&#xD;
          -  Histologically confirmed diagnosis of well-differentiated neuroendocrine tumor.&#xD;
&#xD;
          -  A diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) of the tumor&#xD;
             region within the previous 6 months prior to dosing day is available.&#xD;
&#xD;
          -  At least 1 measurable lesion based on RECIST v1.1.&#xD;
&#xD;
          -  Blood test results as follows (White blood cell: ≥ 3*10^9/L, Hemoglobin: ≥ 8.0 g/dL,&#xD;
             Platelets: ≥ 50x10^9/L, Alanine aminotransferase / Aspartate aminotransferase /&#xD;
             Alkaline phosphatase: ≤ 5 times the upper limit of normal (ULN), Bilirubin: ≤ 3 times&#xD;
             ULN)&#xD;
&#xD;
          -  Serum creatinine: within normal limits or &lt; 120 μmol/L for patients aged 60 years or&#xD;
             older.&#xD;
&#xD;
          -  Calculated Glomerular filtration rate (GFR) ≥ 45 mL/min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to Gallium-68, to NODAGA, to DOTA, to LM3, to JR11 or to any of&#xD;
             the excipients of Gallium-68 DOTA-LM3, Gallium-68 NODAGA-LM3, or Gallium-68&#xD;
             NODAGA-JR11.&#xD;
&#xD;
          -  Presence of active infection at screening or history of serious infection within the&#xD;
             previous 6 weeks.&#xD;
&#xD;
          -  Therapeutic use of any somatostatin analog, including long-acting Sandostatin (within&#xD;
             28 days) and short-acting Sandostatin (within 2 days) prior to study imaging. If a&#xD;
             patient is on long-acting Sandostatina, then a wash-out phase of 28 days is required&#xD;
             before the injection of the study drug. If a patient is on short-acting Sandostatin,&#xD;
             then a wash-out phase of 2 days is required before the injection of the study drug.&#xD;
&#xD;
          -  Any neuroendocrine tumor-specific treatment between scans.&#xD;
&#xD;
          -  Proofs of negative somatostatin receptor expression by previous scans or&#xD;
             Immunohistochemical staining results.&#xD;
&#xD;
          -  Prior or planned administration of a radiopharmaceutical within 8 half-lives of the&#xD;
             radionuclide used on such radiopharmaceutical including at any time during the current&#xD;
             study.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
&#xD;
          -  Current history of any malignancy other than neuroendocrine tumor; patients with a&#xD;
             secondary tumor in remission of &gt; 5 years can be included.&#xD;
&#xD;
          -  Any mental condition rendering the patient unable to understand the nature, scope, and&#xD;
             possible consequences of the study, and/or evidence of an uncooperative attitude.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wenjia Zhu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Uion Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wenjia Zhu, MD</last_name>
    <phone>+86 18614080164</phone>
    <email>zhuwenjia_pumc@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Li Huo, MD</last_name>
    <phone>+86 13910801986</phone>
    <email>huoli@pumch.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yupei Zhao, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>somatostatin receptor antagonist</keyword>
  <keyword>PET/CT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroendocrine Tumors</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04491851
org study id: ANTANET
nct id: NCT04491851
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Somatostatin receptor antagonists are emerging agents in molecular imaging of neuroendocrine
      tumors. There're two main antagonist peptides, namely JR11 and LM3, which can be coupled with
      different chelators, DOTA and NODAGA. Previous studies by our and other groups have revealed
      the different diagnostic performances of these tracers. However, head-to-head comparison data
      is still missing. In this study, we aim to evaluate the diagnostic performance of four
      different antagonists, that is, NODAGA-LM3, DOTA-LM3, and NODAGA-JR11, all labeled with
      gallium-68.
Patients will be randomly assigned into two arms:

      Arm A : 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 Arm B : 68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11

      In each arm, patients will undergo PET/CT using assigned tracers. Lesion detection, lesion
      SUV, and the tumor-to-background ratio will be compared.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomly assigned into four arms:
Arm A : 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 Arm B : 68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
masking description: The details of patient groups will be sealed in sequentially numbered, opaque, sealed envelopes generated by Xuezhu Wang from the nuclear medicine department, Peking Union Medical College Hospital, who will not participate in other parts of the study.
measure: Lesion numbers
time frame: At 1-hours post-injection
description: Determination of lesion numbers of 68Ga-NODAGA-LM3, 68Ga-DOTA-LM3, and 68Ga-NODAGA-JR11 scan.
measure: Standard uptake value (SUV)
time frame: At 1-hours post-injection
description: Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-LM3, 68Ga-DOTA-LM3, and 68Ga-NODAGA-JR11 scan.
arm group label: LM3 group
arm group type: Experimental
description: In this arm, patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-DOTA-LM3 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.
arm group label: NODAGA group
arm group type: Experimental
description: In this arm, patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-NODAGA-JR11 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.
intervention type: Diagnostic Test
intervention name: 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 PET/CT
description: Patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-DOTA-LM3 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.
arm group label: LM3 group
intervention type: Diagnostic Test
intervention name: 68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11 PET/CT
description: Patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-NODAGA-JR11 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.
arm group label: NODAGA group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wenjia Zhu, MD
role: Principal Investigator
affiliation: Peking Uion Medical College Hospital
last name: Wenjia Zhu, MD
phone: +86 18614080164
email: zhuwenjia_pumc@163.com
last name: Li Huo, MD
phone: +86 13910801986
email: huoli@pumch.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Neuroendocrine Tumors
sharing ipd: Undecided