<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/NCT01730638</url>
  </required_header>
  <id_info>
    <org_study_id>PROG/10/94</org_study_id>
    <nct_id>NCT01730638</nct_id>
  </id_info>
  <brief_title>ImmunoTEP for Patients With Medullary Thyroid Carcinoma.</brief_title>
  <acronym>iTEP-CMT</acronym>
  <official_title>Pharmacokinetic and Imaging Optimization Study of Pretargeted Immuno-PET Using the Anti-CEA x Anti-HSG TF2 Bispecific Antibody and 68Ga-IMP-288 Peptide in Patients With Recurrences of Medullary Thyroid Carcinoma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to optimize pretargeting parameters using pharmacokinetic and&#xD;
      imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288&#xD;
      peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at&#xD;
      least one abnormal lesion&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed&#xD;
      in 4 to 5 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of&#xD;
      peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288&#xD;
      injections.&#xD;
&#xD;
      A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body&#xD;
      PET images will be recorded 60 and 120 minutes after 68Ga-IMP-288 injection to assess&#xD;
      semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the targeting&#xD;
      sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard methods of&#xD;
      tumor.&#xD;
&#xD;
      some patient will have a second immuno-TEP for their follow up in the first examen was the&#xD;
      most sensible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288</measure>
    <time_frame>one week</time_frame>
    <description>Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart.&#xD;
A last cohort (number 5 or 6) with optimal conditions will be proposed Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semiquantitatively tumor targeting and tumor/background ratio.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensibilité</measure>
    <time_frame>6 monts after immunoTEP</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>tolerance</measure>
    <time_frame>6 monts after immunoTEP</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>a second _iTEP if necessary for the follow up of a lesion</measure>
    <time_frame>6 monts after immunoTEP</time_frame>
    <description>with in the follow up of the pateint</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Medullary Thyroid Carcinoma</condition>
  <arm_group>
    <arm_group_label>TF2 antibody/68Ga-IMP-288</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TF2 coupled with 68 Ga-IMP-288</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>• TF2 and 68 Ga-IMP-288</intervention_name>
    <arm_group_label>TF2 antibody/68Ga-IMP-288</arm_group_label>
    <other_name>• TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG)</other_name>
    <other_name>• 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological diagnosis of CMT&#xD;
&#xD;
          -  Calcitonin&gt; 150 pg / ml&#xD;
&#xD;
          -  Complete treatment of the primary tumor&#xD;
&#xD;
          -  at least one detectable lesion more than 10 mm on conventional imaging: bone lesions&#xD;
             can be taken into account if they extend outside of the bone and the party extra bone&#xD;
             is measurable.&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Negative pregnancy test for women of childbearing age in the previous 2 days&#xD;
             immuno-PET. Women of childbearing potential should use effective contraception take&#xD;
             continuously for 3 months.&#xD;
&#xD;
          -  KPS ≥ 70 or ECOG 0-1 and life expectancy of at least 6 months&#xD;
&#xD;
          -  Absence of serious illness or co-morbidity assessed risk&#xD;
&#xD;
          -  Creatinine ≤ 2.5 normal&#xD;
&#xD;
          -  Absence of cancer treatment within 6 weeks prior to the immuno-PET&#xD;
&#xD;
          -  No history of cancer within 5 years, except skin cancer other than melanoma or&#xD;
             carcinoma in situ of the cervix&#xD;
&#xD;
          -  Lack of anti-antibodies in patients who have previously received antibodies and&#xD;
             hypersensitivity to antibody or protein&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
          -  Social Insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Serious illness or co-morbidity assessed risk&#xD;
&#xD;
          -  History of cancer within 5 years, except skin cancer other than melanoma or carcinoma&#xD;
             in situ of the cervix&#xD;
&#xD;
          -  Presence of anti-antibodies in patients who have previously received antibodies&#xD;
&#xD;
          -  Known hypersensitivity to antibody or protein&#xD;
&#xD;
          -  Need to establish a cancer treatment within 3 months of immuno-PET (before stock&#xD;
             evaluation 3 months)&#xD;
&#xD;
          -  Inability intellectual sign consent&#xD;
&#xD;
          -  Patient protected by law&#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>Francoise Bodere, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Angers Hospital</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nantes Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de l'ouest, René Gauducheau</name>
      <address>
        <city>Saint-Herblain</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>July 22, 2022</last_update_submitted>
  <last_update_submitted_qc>July 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>thyroid,</keyword>
  <keyword>endocrine tumour</keyword>
  <keyword>Nuclear medicine,</keyword>
  <keyword>molecular imaging</keyword>
  <keyword>ImmunoTEP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Neuroendocrine</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Histamine</mesh_term>
    <mesh_term>Glycine</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/NCT01730638
org study id: PROG/10/94
nct id: NCT01730638
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The aim of this study is to optimize pretargeting parameters using pharmacokinetic and
      imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288
      peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at
      least one abnormal lesion
Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed
      in 4 to 5 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of
      peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288
      injections.

      A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body
      PET images will be recorded 60 and 120 minutes after 68Ga-IMP-288 injection to assess
      semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the targeting
      sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard methods of
      tumor.

      some patient will have a second immuno-TEP for their follow up in the first examen was the
      most sensible.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
time frame: one week
description: Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart.
A last cohort (number 5 or 6) with optimal conditions will be proposed Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semiquantitatively tumor targeting and tumor/background ratio.
measure: Sensibilité
time frame: 6 monts after immunoTEP
measure: tolerance
time frame: 6 monts after immunoTEP
measure: a second _iTEP if necessary for the follow up of a lesion
time frame: 6 monts after immunoTEP
description: with in the follow up of the pateint
arm group label: TF2 antibody/68Ga-IMP-288
arm group type: Experimental
description: TF2 coupled with 68 Ga-IMP-288
intervention type: Drug
intervention name: • TF2 and 68 Ga-IMP-288
arm group label: TF2 antibody/68Ga-IMP-288
other name: • TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG)
other name: • 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francoise Bodere, PhD, MD
role: Principal Investigator
affiliation: Nantes Hospital
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Thyroid Neoplasms
mesh term: Carcinoma, Neuroendocrine
mesh term: Thyroid Diseases
mesh term: Histamine
mesh term: Glycine