<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/NCT02234375</url>
  </required_header>
  <id_info>
    <org_study_id>2012P002535b</org_study_id>
    <nct_id>NCT02234375</nct_id>
  </id_info>
  <brief_title>Use of Gadolinium in CT Pulmonary Angiography</brief_title>
  <official_title>Efficacy of Gadolinium Contrast in CT Pulmonary Angiography in Patients With Allergy to Iodine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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>
      The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who&#xD;
      have a contraindication to iodine based contrast. These patients normally get investigated&#xD;
      with studies such as ultrasound and nuclear medicine studies but the fastest and preferred&#xD;
      investigation is CT with contrast to look for filling defects in the pulmonary arteries. The&#xD;
      investigators will assess whether gadolinium, which is currently used with MRI can be used&#xD;
      with CT as an alternative effective contrast in diagnosis or exclusion of PE. A new type of&#xD;
      CT scanner, a Dual Energy Scanner will be used to improve the visibility of Gadolinium&#xD;
      contrast on CT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Contrast enhancement with Gadolinium will be evaluated to assess its efficacy for diagnosis&#xD;
      and exclusion of pulmonary embolism in a patient who previously would not have been&#xD;
      investigated with CTPA due to an underlying allergy to contrast or other contraindication. If&#xD;
      this proves beneficial, it will allow such patients to be investigated successfully with CTPA&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Gadolinium attenuation in vitro inadequate&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 4</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>Diagnosis of Pulmonary Embolism</measure>
    <time_frame>24 hours</time_frame>
    <description>Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>Gadolinium enhancement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gadolinium enhancement will be performed using intravenous Dotarem[recommended dose of 0.2 mL/kg (0.1 mmol Gd/kg )]</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gadolinium</intervention_name>
    <description>agents will be administered intravenously and a CT scan will be performed to evaluate contrast enhancement characteristics of the agents to assess their feasibility as an alternative to Iodine based contrast agents</description>
    <arm_group_label>Gadolinium enhancement</arm_group_label>
    <other_name>Dotarem</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suspected of having a Pulmonary embolus&#xD;
&#xD;
          -  Allergy to Iodine based intravenous contrast&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Renal impairment&#xD;
&#xD;
          -  Less than 20 years of age&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Allergy to Gadolinium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>February 13, 2020</last_update_submitted>
  <last_update_submitted_qc>February 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Amita Sharma, MD</investigator_full_name>
    <investigator_title>Radiologist</investigator_title>
  </responsible_party>
  <keyword>Pulmonary embolism</keyword>
  <keyword>Contrast</keyword>
  <keyword>Computed tomography</keyword>
  <keyword>Gadolinium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_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/NCT02234375
org study id: 2012P002535b
nct id: NCT02234375
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who
      have a contraindication to iodine based contrast. These patients normally get investigated
      with studies such as ultrasound and nuclear medicine studies but the fastest and preferred
      investigation is CT with contrast to look for filling defects in the pulmonary arteries. The
      investigators will assess whether gadolinium, which is currently used with MRI can be used
      with CT as an alternative effective contrast in diagnosis or exclusion of PE. A new type of
      CT scanner, a Dual Energy Scanner will be used to improve the visibility of Gadolinium
      contrast on CT.
Contrast enhancement with Gadolinium will be evaluated to assess its efficacy for diagnosis
      and exclusion of pulmonary embolism in a patient who previously would not have been
      investigated with CTPA due to an underlying allergy to contrast or other contraindication. If
      this proves beneficial, it will allow such patients to be investigated successfully with CTPA
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnosis of Pulmonary Embolism
time frame: 24 hours
description: Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan
arm group label: Gadolinium enhancement
arm group type: Experimental
description: Gadolinium enhancement will be performed using intravenous Dotarem[recommended dose of 0.2 mL/kg (0.1 mmol Gd/kg )]
intervention type: Drug
intervention name: Gadolinium
description: agents will be administered intravenously and a CT scan will be performed to evaluate contrast enhancement characteristics of the agents to assess their feasibility as an alternative to Iodine based contrast agents
arm group label: Gadolinium enhancement
other name: Dotarem
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Amita Sharma, MD
investigator title: Radiologist
mesh term: Pulmonary Embolism
mesh term: Embolism