<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/NCT03750188</url>
  </required_header>
  <id_info>
    <org_study_id>PH-108</org_study_id>
    <nct_id>NCT03750188</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety and Efficacy of ProHance in Pediatric Patients &lt;2yrs</brief_title>
  <official_title>The Safety and Efficacy of ProHance® at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients Who Are Younger Than 2 Years of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bracco Diagnostics, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bracco Diagnostics, Inc</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>
      Safety and Efficacy Study in pediatric subjects &lt;2 years of age who have undergone Brain or&#xD;
      Spine MRI pre and post 0.1 mmol/kg ProHance administration. Imaging conditions will represent&#xD;
      those in routine clinical practice. Retrospective enrolment with a prospective blinded read.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to retrospectively enroll children younger than 2 years of age&#xD;
      who have undergone brain or spine MRI with 0.1 mmol/kg PROHANCE and to gather safety data as&#xD;
      well as to collect MR images for a prospective blinded read to evaluate the efficacy of&#xD;
      PROHANCE in terms of visualization and enhancing properties.&#xD;
&#xD;
      The study will be conducted in 4-8 sites in the United States and Europe. It is estimated&#xD;
      that 120 patients will be enrolled to provide 108 evaluable patients.&#xD;
&#xD;
      Three radiologists unaffiliated with enrolling centers (blinded readers), blinded to the&#xD;
      patient's identity and clinical profile will independently evaluate the MRI images. The&#xD;
      efficacy analysis will be primarily based on the blinded reader evaluations.&#xD;
&#xD;
      Imaging conditions will represent those in routine clinical practice, inclusive of pre and&#xD;
      post-contrast images.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">October 16, 2019</completion_date>
  <primary_completion_date type="Actual">September 17, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Border delineation of lesions</measure>
    <time_frame>Immediately post dose - Day 1</time_frame>
    <description>Blinded reader will assess the border delineation of lesion based on a 5 point scale, none (0) - Excellent (4)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visualization of internal morphology of lesions</measure>
    <time_frame>Immediately post dose - Day 1</time_frame>
    <description>Blinded reader will assess the visualization of internal morphology of the lesion(s) based on a 5 point scale, none (0) - Excellent (4)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Contrast enhancement of lesions</measure>
    <time_frame>Immediately post dose- Day 1</time_frame>
    <description>Blinded reader will assess the contrast enhancement of the lesion(s) based on a 5 point scale, none (0) - Excellent (4)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and percentage of subjects with ProHance Related Adverse Events</measure>
    <time_frame>up to 2 hours post-dose</time_frame>
    <description>In terms of frequency, type and severity of adverse events Data collected, will consist of Screening Serum Creatinine value (mg/dL), If available, Vital signs (systolic blood pressure, diastolic blood pressure, heart rate, respiration rate) and ECG.</description>
  </primary_outcome>
  <enrollment type="Actual">125</enrollment>
  <condition>Central Nervous System Diseases</condition>
  <condition>Central Nervous System Neoplasms</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ProHance</intervention_name>
    <description>0.1 mmol/kg ProHance intravenous injection</description>
    <other_name>Gadoteridol</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include patients younger than 2 years of age who have previously undergone&#xD;
        MRI of the CNS (brain or spine) with PROHANCE at the dose of 0.1 mmol/kg as part of their&#xD;
        clinical work-up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is male or female and was younger than 2 years of age at the time of the MRI with&#xD;
             PROHANCE injection at the dose of 0.1 mmol/kg (±25% in volume administered).&#xD;
&#xD;
          -  Has demographic information, reason for the ProHance-enhanced MR examination, relevant&#xD;
             medical history, final diagnosis, and safety data available.&#xD;
&#xD;
          -  Has documented known or highly suspected enhancing disease of CNS (brain/spine) and&#xD;
             previously underwent a cranial or spinal MR examination requiring an injection of&#xD;
             PROHANCE contrast agent.&#xD;
&#xD;
          -  Has both predose and postdose T1 SE/FSE and/or GRE and T2 SE/FSE, and FLAIR MR images&#xD;
             (when available) for submission to Bracco or designee to be evaluated in a fully&#xD;
             blinded read.&#xD;
&#xD;
          -  Has complete information on the imaging protocol used for the ProHance-enhanced MR&#xD;
             exam including type of exam (brain or spine), MR scanner and field strength (1.0, 1.5&#xD;
             or 3.0 Tesla)&#xD;
&#xD;
          -  Has a documented dose of PROHANCE administered for their MRI exam and/or the volume&#xD;
             (mL) and weight of the patient available to be used to calculate the exact dose of&#xD;
             PROHANCE that was administered.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Exclude a patient from this study if the patient does not fulfill all of the inclusion&#xD;
        criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gianpaolo Pirovano, MD</last_name>
    <role>Study Director</role>
    <affiliation>Bracco Diagnostics, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CNS</keyword>
  <keyword>MRI</keyword>
  <keyword>ProHance</keyword>
  <keyword>Gadoteridol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Neoplasms</mesh_term>
    <mesh_term>Central Nervous System Neoplasms</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03750188
org study id: PH-108
nct id: NCT03750188
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Safety and Efficacy Study in pediatric subjects <2 years of age who have undergone Brain or
      Spine MRI pre and post 0.1 mmol/kg ProHance administration. Imaging conditions will represent
      those in routine clinical practice. Retrospective enrolment with a prospective blinded read.
The purpose of this study is to retrospectively enroll children younger than 2 years of age
      who have undergone brain or spine MRI with 0.1 mmol/kg PROHANCE and to gather safety data as
      well as to collect MR images for a prospective blinded read to evaluate the efficacy of
      PROHANCE in terms of visualization and enhancing properties.

      The study will be conducted in 4-8 sites in the United States and Europe. It is estimated
      that 120 patients will be enrolled to provide 108 evaluable patients.

      Three radiologists unaffiliated with enrolling centers (blinded readers), blinded to the
      patient's identity and clinical profile will independently evaluate the MRI images. The
      efficacy analysis will be primarily based on the blinded reader evaluations.

      Imaging conditions will represent those in routine clinical practice, inclusive of pre and
      post-contrast images.
observational model: Case-Only
time perspective: Retrospective
measure: Border delineation of lesions
time frame: Immediately post dose - Day 1
description: Blinded reader will assess the border delineation of lesion based on a 5 point scale, none (0) - Excellent (4)
measure: Visualization of internal morphology of lesions
time frame: Immediately post dose - Day 1
description: Blinded reader will assess the visualization of internal morphology of the lesion(s) based on a 5 point scale, none (0) - Excellent (4)
measure: Contrast enhancement of lesions
time frame: Immediately post dose- Day 1
description: Blinded reader will assess the contrast enhancement of the lesion(s) based on a 5 point scale, none (0) - Excellent (4)
measure: Number and percentage of subjects with ProHance Related Adverse Events
time frame: up to 2 hours post-dose
description: In terms of frequency, type and severity of adverse events Data collected, will consist of Screening Serum Creatinine value (mg/dL), If available, Vital signs (systolic blood pressure, diastolic blood pressure, heart rate, respiration rate) and ECG.
intervention type: Drug
intervention name: ProHance
description: 0.1 mmol/kg ProHance intravenous injection
other name: Gadoteridol
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 2 Years
healthy volunteers: No
last name: Gianpaolo Pirovano, MD
role: Study Director
affiliation: Bracco Diagnostics, Inc
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nervous System Neoplasms
mesh term: Central Nervous System Neoplasms
mesh term: Nervous System Diseases
mesh term: Central Nervous System Diseases
sharing ipd: No