<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/NCT02241525</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00063432</org_study_id>
    <nct_id>NCT02241525</nct_id>
  </id_info>
  <brief_title>CT for Pulmonary Thromboembolic Disease</brief_title>
  <acronym>CT for PE</acronym>
  <official_title>Individually Optimized Uniform Contrast Enhancement in CT Angiography for the Diagnosis of Pulmonary Thromboembolic Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Examine the feasibility and efficacy of individually optimized uniform contrast enhancement&#xD;
      in CT pulmonary angiography (CTPA) for the diagnosis of pulmonary thromboembolic disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient characteristics, qualitative image quality scores, and quantitative contrast&#xD;
      enhancement and CNR will be described using mean values and standard deviations for&#xD;
      continuous variables, and frequencies and percent for categorical variables. Difference&#xD;
      between the two patient groups will be compared using Wilcoxon signed rank tests and&#xD;
      chi-square statistics for continuous and categorical variables, respectively. All statistical&#xD;
      tests will be performed at a significance level of 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The PI left the university&#xD;
  </why_stopped>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of patients with individually optimized bi-phasic contrast injection for CTPA scan</measure>
    <time_frame>1 year</time_frame>
    <description>The primary endpoint is to study the feasibility( bi-phasic vs. singular pahse contrast injection (by comparison analysis)) of individually optimized bi-phasic contrast injection for CTPA scan.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of PE diagnosis with CTPA imaging</measure>
    <time_frame>1 year</time_frame>
    <description>To quantify the efficacy (by comparison analysis) of PE diagnosis of this new contrast injection protocol in terms of reduced frequency of non-diagnostic CTPA image vs. standard of care procedures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure># of patients who receive contrast enhancement and CNR of CTPA scans</measure>
    <time_frame>1 year</time_frame>
    <description>A secondary endpoint is to quantitatively evaluate (by comparison analysis) the contrast enhancement and CNR of CTPA scans. Twenty patients (20) will be enrolled and scanned with the RESEARCH procedures. Another twenty retrospective patients (20) with matching age and BMI will be selected from existing patients with a CLINICAL STANDARD of Care CTPA scan and enrolled on retrospective protocol:&#xD;
HP-00056512 &quot;Individually optimized uniform contrast enhancement in CT angiography for the diagnosis of pulmonarythromboembolic disease - A simulation study&quot;.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2</enrollment>
  <condition>Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>Prospective</arm_group_label>
    <description>Twenty patients will be enrolled and scanned with the RESEARCH procedures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retrospective</arm_group_label>
    <description>Patients with matching age and BMI will be selected from existing patients with a CLINICAL STANDARD of Care CTPA scan.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Obese patients for a diagnosis of PE&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years old or older&#xD;
&#xD;
          -  Patients who have been recommended for CTPA scan for the diagnosis of pulmonary;&#xD;
             thromboembolic disease (PE) in the Department of Diagnostic Radiology and Nuclear&#xD;
             Medicine at the University of Maryland-Patients whose body mass index (BMI) is greater&#xD;
             than 30 kg/m2.&#xD;
&#xD;
          -  Patients whose body mass index (BMI) is greater than 30 kg/m2&#xD;
&#xD;
          -  Patients who signed the University of Maryland Medical Center Consent for Intravenous&#xD;
             Contrast Administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding women; Female participants of childbearing age (10 - 60&#xD;
             years) will be screened for their pregnancy status prior to study registration, by&#xD;
             following the Department of Diagnostic Radiology and Nuclear Medicine CLINICAL&#xD;
             STANDARD Procedure DI-AOP-003 &quot;Pregnancy Screening Documentation&quot;; - Patients with&#xD;
             decreased renal function34-36. This is evaluated by blood work checked within 30 days&#xD;
             prior to the CTPA scan with contrast. Patients cannot receive contrast if their BUN&#xD;
             index is not within [7-20] or creatinine is not within [0.5 - 1.4] mg/dL&#xD;
&#xD;
          -  Patients with decreased renal function34-36. This is evaluated by blood work checked&#xD;
             within current admission for inpatients or within 30 days for outpatients prior to the&#xD;
             CTPA scan with contrast. Patients cannot receive contrast if their serum creatinine&#xD;
             level exceeds 2.0 mg/dL&#xD;
&#xD;
          -  Patients with known moderate or severe allergic reactions to contrast, including but&#xD;
             not limited to: shortness of breath, a change in baseline vital signs, such as a&#xD;
             change in blood pressure, tachycardia, increased respirations that can progress to&#xD;
             major respiratory distress, laryngeal edema, bronchospasm, arrhythmias, convulsions,&#xD;
             and cardiopulmonary arrest.&#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>Wei Lu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univerysity of Maryland Baltimore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Department of Radiation Oncology</investigator_full_name>
    <investigator_title>Site Investigator</investigator_title>
  </responsible_party>
  <keyword>Pulmonary</keyword>
  <keyword>Thromboembolic</keyword>
  <keyword>Lung</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>
    <mesh_term>Thromboembolism</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/NCT02241525
org study id: HP-00063432
nct id: NCT02241525
lead sponsor: 
has dmc: Yes
Examine the feasibility and efficacy of individually optimized uniform contrast enhancement
      in CT pulmonary angiography (CTPA) for the diagnosis of pulmonary thromboembolic disease.
Patient characteristics, qualitative image quality scores, and quantitative contrast
      enhancement and CNR will be described using mean values and standard deviations for
      continuous variables, and frequencies and percent for categorical variables. Difference
      between the two patient groups will be compared using Wilcoxon signed rank tests and
      chi-square statistics for continuous and categorical variables, respectively. All statistical
      tests will be performed at a significance level of 0.05.
observational model: Case-Control
time perspective: Prospective
measure: Feasibility of patients with individually optimized bi-phasic contrast injection for CTPA scan
time frame: 1 year
description: The primary endpoint is to study the feasibility( bi-phasic vs. singular pahse contrast injection (by comparison analysis)) of individually optimized bi-phasic contrast injection for CTPA scan.
measure: Efficacy of PE diagnosis with CTPA imaging
time frame: 1 year
description: To quantify the efficacy (by comparison analysis) of PE diagnosis of this new contrast injection protocol in terms of reduced frequency of non-diagnostic CTPA image vs. standard of care procedures.
measure: # of patients who receive contrast enhancement and CNR of CTPA scans
time frame: 1 year
description: A secondary endpoint is to quantitatively evaluate (by comparison analysis) the contrast enhancement and CNR of CTPA scans. Twenty patients (20) will be enrolled and scanned with the RESEARCH procedures. Another twenty retrospective patients (20) with matching age and BMI will be selected from existing patients with a CLINICAL STANDARD of Care CTPA scan and enrolled on retrospective protocol:
HP-00056512 "Individually optimized uniform contrast enhancement in CT angiography for the diagnosis of pulmonarythromboembolic disease - A simulation study".
arm group label: Prospective
description: Twenty patients will be enrolled and scanned with the RESEARCH procedures
arm group label: Retrospective
description: Patients with matching age and BMI will be selected from existing patients with a CLINICAL STANDARD of Care CTPA scan.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wei Lu, PhD
role: Principal Investigator
affiliation: Univerysity of Maryland Baltimore
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Department of Radiation Oncology
investigator title: Site Investigator
mesh term: Pulmonary Embolism
mesh term: Embolism
mesh term: Thromboembolism
sharing ipd: No