<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/NCT04467567</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A20200-620</org_study_id>
    <nct_id>NCT04467567</nct_id>
  </id_info>
  <brief_title>Dosimetry Using a CZT-camera Following LUTATHERA® Therapy</brief_title>
  <acronym>EVADOVE177Lu</acronym>
  <official_title>Optimization for Clinical Routine of a Dosimetry Protocol Using the Large Field of View VERITON-CT CZT Camera in Patients Treated With LUTATHERA® [177Lu- [DOTA0, Tyr3] -Octreotate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      The aim of this study is to assess the consistency between a dosimetry protocol using a large&#xD;
      field of view CZT-camera and the dosimetry protocol used for recordings acquired with a&#xD;
      conventional camera. Therefore, with the conventional camera, recordings are acquired on the&#xD;
      &quot;high energy&quot; peak of lutetium 177 (208 keV) using a medium energy collimator. With the&#xD;
      VERITON-CT™ CZT camera, recordings are acquired using the low energy peak of 113 keV. A&#xD;
      second objective is to compare results between the dosimetry calculated using 3 measurement&#xD;
      points (24h, 96h and 168h) and the dosimetry calculated using 2 measurement points (24h and&#xD;
      168h), obtained from the SYMBIA T conventional camera and the VERITON-CT™camera,&#xD;
      respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      177Lu-DOTATATE has been proven to be an effective therapy for treatment of neuroendocrine&#xD;
      tumors. Treatment with [177Lu]-DOTA-TATE consists of 4 cycles, with an infusion of 7.4 GBq&#xD;
      (200mCi) every 8 weeks. An imaging protocol to study dosimetry throughout the cycles is&#xD;
      essential to determine the average dose absorbed by critical organs and by tumor lesions. The&#xD;
      critical organs studied in association with [177Lu]-octreotate treatment are predominantly&#xD;
      kidneys and the bone marrow. In this open-label trial, 15 patients undergoing Lutathera®&#xD;
      treatment could be enrolled in the study. Patients will have an abdominopelvic SPECT / CT&#xD;
      recorded using a conventional Anger camera, followed by a whole-body SPECT / CT recording&#xD;
      using a CZT camera. Recordings will be acquired at 24 hours, 96 hours and then at 7 days&#xD;
      after the Lutathera® infusion that is administered during one of the 4 treatment cycles. The&#xD;
      correlation between the dosimetry results and the appearance of possible grade 3 and 4 side&#xD;
      effects will be established.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 27, 2020</start_date>
  <completion_date type="Anticipated">November 25, 2022</completion_date>
  <primary_completion_date type="Actual">March 25, 2021</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Results of the dosimetry obtained from the 2 cameras</measure>
    <time_frame>168 hours</time_frame>
    <description>Comparison between dosimetry results obtained from the conventional camera and from the VERITON-CT™ CZT camera.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Results of the dosimetry obtained from the 2 cameras when utilizing 3 points of measurement and when utilizing 2 points of measurement</measure>
    <time_frame>24 hours, 96 hours, 168 hours</time_frame>
    <description>Measurement of the average absorbed doses to sensitive organs (bone marrow and kidneys) and to tumor lesions obtained when utilizing 3 measurement points (24h, 96h and 168h) and then obtained when utilizing 2 measurement points (24h and 168h) after the administration of Lutathera®, from both a VERITON-CT™ camera and from a SYMBIA T camera.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the dosimetry results</measure>
    <time_frame>24 hours, 96 hours, 168 hours</time_frame>
    <description>Average absorbed doses to the kidneys and to the bone marrow versus renal function (creatininaemia, glomerular filtration rate [GFR], blood ionogram), and versus bone marrow activity (blood count).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Dosimetry</condition>
  <arm_group>
    <arm_group_label>patients treated with lutathera</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing treatment with Lutathera® and who accept to participate in the study, regardless of the cycle of treatment, 1, 2, 3 or 4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)</intervention_name>
    <description>SPECT/CT will be performed after Lutathera® treatment (at 24h, 96h and 168h after the infusion of Lutathera®) on the conventional camera and on the VERITON-CT camera</description>
    <arm_group_label>patients treated with lutathera</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major adult subject&#xD;
&#xD;
          -  ECOG ≤ 2&#xD;
&#xD;
          -  Subject receiving treatment with Lutathera®&#xD;
&#xD;
          -  Subject having given written, free and informed consent&#xD;
&#xD;
          -  Affiliation to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to treatment with Lutathera®&#xD;
&#xD;
          -  Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health&#xD;
             code.&#xD;
&#xD;
          -  Pregnant woman, parturient or nursing mother.&#xD;
&#xD;
          -  Subject with a legal protection measure (guardianship, curatorship, safeguard of&#xD;
             justice).&#xD;
&#xD;
          -  Subject unable to express consent.&#xD;
&#xD;
          -  Subject deprived of their liberty by a judicial or administrative decision, persons&#xD;
             subject to psychiatric care under Articles L. 3212-1 and L.3213-1&#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_contact>
    <last_name>Elodie Chevalier, MD</last_name>
    <phone>+33(0)3 83 15 74 02</phone>
    <email>e.chevalier@chru-nancy.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laetitia IMBERT, PhD</last_name>
    <phone>+33(0)3 83 15 78 79</phone>
    <email>l.imbert@chru-nancy.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chru Nancy</name>
      <address>
        <city>Vandoeuvre/les/nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Véronique ROCH, MSc</last_name>
      <phone>+33383154276</phone>
      <email>v.roch@chru-nancy.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04467567
org study id: 2020-A20200-620
nct id: NCT04467567
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the consistency between a dosimetry protocol using a large
      field of view CZT-camera and the dosimetry protocol used for recordings acquired with a
      conventional camera. Therefore, with the conventional camera, recordings are acquired on the
      "high energy" peak of lutetium 177 (208 keV) using a medium energy collimator. With the
      VERITON-CT™ CZT camera, recordings are acquired using the low energy peak of 113 keV. A
      second objective is to compare results between the dosimetry calculated using 3 measurement
      points (24h, 96h and 168h) and the dosimetry calculated using 2 measurement points (24h and
      168h), obtained from the SYMBIA T conventional camera and the VERITON-CT™camera,
      respectively.
177Lu-DOTATATE has been proven to be an effective therapy for treatment of neuroendocrine
      tumors. Treatment with [177Lu]-DOTA-TATE consists of 4 cycles, with an infusion of 7.4 GBq
      (200mCi) every 8 weeks. An imaging protocol to study dosimetry throughout the cycles is
      essential to determine the average dose absorbed by critical organs and by tumor lesions. The
      critical organs studied in association with [177Lu]-octreotate treatment are predominantly
      kidneys and the bone marrow. In this open-label trial, 15 patients undergoing Lutathera®
      treatment could be enrolled in the study. Patients will have an abdominopelvic SPECT / CT
      recorded using a conventional Anger camera, followed by a whole-body SPECT / CT recording
      using a CZT camera. Recordings will be acquired at 24 hours, 96 hours and then at 7 days
      after the Lutathera® infusion that is administered during one of the 4 treatment cycles. The
      correlation between the dosimetry results and the appearance of possible grade 3 and 4 side
      effects will be established.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Results of the dosimetry obtained from the 2 cameras
time frame: 168 hours
description: Comparison between dosimetry results obtained from the conventional camera and from the VERITON-CT™ CZT camera.
measure: Results of the dosimetry obtained from the 2 cameras when utilizing 3 points of measurement and when utilizing 2 points of measurement
time frame: 24 hours, 96 hours, 168 hours
description: Measurement of the average absorbed doses to sensitive organs (bone marrow and kidneys) and to tumor lesions obtained when utilizing 3 measurement points (24h, 96h and 168h) and then obtained when utilizing 2 measurement points (24h and 168h) after the administration of Lutathera®, from both a VERITON-CT™ camera and from a SYMBIA T camera.
measure: Correlation between the dosimetry results
time frame: 24 hours, 96 hours, 168 hours
description: Average absorbed doses to the kidneys and to the bone marrow versus renal function (creatininaemia, glomerular filtration rate [GFR], blood ionogram), and versus bone marrow activity (blood count).
arm group label: patients treated with lutathera
arm group type: Experimental
description: Patients undergoing treatment with Lutathera® and who accept to participate in the study, regardless of the cycle of treatment, 1, 2, 3 or 4.
intervention type: Other
intervention name: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)
description: SPECT/CT will be performed after Lutathera® treatment (at 24h, 96h and 168h after the infusion of Lutathera®) on the conventional camera and on the VERITON-CT camera
arm group label: patients treated with lutathera
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elodie Chevalier, MD
phone: +33(0)3 83 15 74 02
email: e.chevalier@chru-nancy.fr
last name: Laetitia IMBERT, PhD
phone: +33(0)3 83 15 78 79
email: l.imbert@chru-nancy.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor