<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/NCT02242448</url>
  </required_header>
  <id_info>
    <org_study_id>140158</org_study_id>
    <secondary_id>14-CC-0158</secondary_id>
    <nct_id>NCT02242448</nct_id>
  </id_info>
  <brief_title>Imaging Techniques in CT: Technical Development</brief_title>
  <official_title>Imaging Techniques in CT: Technical Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institutes of Health Clinical Center (CC)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - Computed tomography (CT) scanning is a procedure that helps doctors with diagnoses. It uses&#xD;
      X-ray radiation to produce an image in three dimensions. Researchers want to study how to get&#xD;
      the best quality CT scans using the lowest possible radiation dose.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      - To determine how to improve CT scanning.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Adults 45 years of age and older who have not had a CT scan in the past year and do not&#xD;
      have kidney disease.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be screened with a medical history and blood and urine tests.&#xD;
&#xD;
        -  Nurses will put an intravenous (IV) line into an arm or hand vein. It will stay in for&#xD;
           several hours during the magnetic resonance imaging (MRI) and CT scans. Through this IV,&#xD;
           blood will be taken, dye will be injected, and medicine will be given.&#xD;
&#xD;
        -  Participants may have a CT scan of the heart, head, chest, abdomen, and/or pelvis.&#xD;
           Participants will lie on their back on a table. The table will slide into a donut-shaped&#xD;
           machine. An X-ray tube will move around the body, taking pictures.&#xD;
&#xD;
        -  Participants may be given a drug called a beta blocker by mouth or through the IV tube.&#xD;
&#xD;
        -  Participants heart rate and blood pressure will be monitored.&#xD;
&#xD;
        -  Participants may have an MRI scan. The MRI is a large hollow tube. The participant will&#xD;
           lie on a table that will be moved into the tube, which contains a magnetic field. When&#xD;
           the imaging starts, a thumping sound will be heard. Headphones or earplugs will be&#xD;
           provided to muffle the sound.&#xD;
&#xD;
        -  Participants will give blood samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this protocol, computed tomography (CT) imaging performed on healthy volunteers and&#xD;
      subjects with disease will be used to test, develop and optimize CT protocols. The results of&#xD;
      this optimization will be used to evaluate the performance of new imaging methods and&#xD;
      equipment, and to provide essential ground work for research and development for use in&#xD;
      future patient CT studies. CT imaging is a noninvasive technology. As appropriate, MRI scans&#xD;
      will be used to compare to CT imaging findings to help validate the CT methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>July 31, 2014</start_date>
  <completion_date type="Actual">October 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To enhance imaging quality and safety</measure>
    <time_frame>ongoing</time_frame>
  </primary_outcome>
  <enrollment type="Actual">109</enrollment>
  <condition>Healthy Volunteers</condition>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  For new or healthy volunteers currently participating in an NIH trial: no CT scan in&#xD;
             the last year OR For patients enrolled in a treatment or interventional trial at the&#xD;
             NIH: no CT scan in the last 6 months&#xD;
&#xD;
          -  Lab Eligibility parameters:&#xD;
&#xD;
               -  For CT and MRI contrast enhanced scans:&#xD;
&#xD;
                  ---eGFR greater than or equal to 60 mL/min/1.73m(2) within 7 days prior to&#xD;
                  scanning&#xD;
&#xD;
               -  For female participants ages 45-60 within 3 days prior to scan (unless&#xD;
                  post-menopausal or no longer able to bear children, note exemption on initial&#xD;
                  visit):&#xD;
&#xD;
                    -  Pregnancy test result(blood or urine): Negative&#xD;
&#xD;
          -  Willing to travel to the NIH for follow-up visits.&#xD;
&#xD;
          -  Greater than or equal to 45 years old&#xD;
&#xD;
          -  Able to understand and sign informed consent&#xD;
&#xD;
          -  Stable clinical status&#xD;
&#xD;
          -  Volunteer indicates no history of participation in NIH protocols using research&#xD;
             radiation in the last 12 months (e.g. PET research scans, NCI Molecular Imaging Center&#xD;
             PET scans, etc)&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Prior CT scan in the last 12 months for new volunteers or healthy volunteers enrolled&#xD;
             in NIH trials OR Prior CT scan in the last 6 months for patients enrolled in a&#xD;
             treatment or interventional trial&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Over 500 lbs and/or a body circumference that prevents the study subject from lying&#xD;
             flat in the scanner&#xD;
&#xD;
          -  Claustrophobia requiring sedation or anesthesia.&#xD;
&#xD;
          -  Known or suspected genetic predisposition to cancer&#xD;
&#xD;
          -  Any contraindications that the research team identifies from the subject, radiology&#xD;
             department CT and/or MRI questionnaires, and/or History and Assessment.&#xD;
&#xD;
        Exclusion for participation for iodinated contrast for CT&#xD;
&#xD;
        (Inclusive of the above exclusion criteria):&#xD;
&#xD;
          -  Allergy to iodinated contrast for scans (study subject will be eligible for&#xD;
             non-contrast scans)&#xD;
&#xD;
          -  Acute renal failure, renal transplant, dialysis and renal failure (clinically&#xD;
             diagnosed).&lt;TAB&gt;&#xD;
&#xD;
          -  Lactating women&#xD;
&#xD;
          -  Patient preference to not undergo intravenous line placement and/or receive iodinated&#xD;
             contrast. Contrast administration is optional and participants may still undergo a&#xD;
             non-contrast study.&#xD;
&#xD;
          -  Use of metformin-containing products less than 24 hours prior To CT contrast&#xD;
             administration&#xD;
&#xD;
          -  Other contraindications to iodinated contrast media as determined by the research&#xD;
             team.&#xD;
&#xD;
        Exclusion for participation for Gadolinium contrast for MRI&#xD;
&#xD;
        (Inclusive of the above exclusion criteria):&#xD;
&#xD;
          -  Allergy to gadolinium for scans using contrast; will be eligible for non-contrast&#xD;
             scans.&#xD;
&#xD;
          -  Acute renal failure, renal transplant, dialysis and renal failure individuals ( Lab&#xD;
             Eligibility parameters and/or clinically diagnosed).&lt;TAB&gt;&#xD;
&#xD;
          -  Lactating women&#xD;
&#xD;
          -  Patient preference to not undergo intravenous line placement and/or receive gadolinium&#xD;
             contrast. Contrast administration is optional and participants may still undergo a&#xD;
             non-contrast study.&#xD;
&#xD;
          -  Other contraindications to gadolinium contrast media as determined by the research&#xD;
             team.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David A Bluemke, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institutes of Health Clinical Center (CC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center, 9000 Rockville Pike</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Halliburton S, Arbab-Zadeh A, Dey D, Einstein AJ, Gentry R, George RT, Gerber T, Mahesh M, Weigold WG. State-of-the-art in CT hardware and scan modes for cardiovascular CT. J Cardiovasc Comput Tomogr. 2012 May-Jun;6(3):154-63. doi: 10.1016/j.jcct.2012.04.005. Epub 2012 Apr 7.</citation>
    <PMID>22551595</PMID>
  </reference>
  <reference>
    <citation>Trattner S, Pearson GDN, Chin C, Cody DD, Gupta R, Hess CP, Kalra MK, Kofler JM Jr, Krishnam MS, Einstein AJ. Standardization and optimization of CT protocols to achieve low dose. J Am Coll Radiol. 2014 Mar;11(3):271-278. doi: 10.1016/j.jacr.2013.10.016.</citation>
    <PMID>24589403</PMID>
  </reference>
  <reference>
    <citation>Mahesh M. Variability in CT protocols. J Am Coll Radiol. 2013 Oct;10(10):805-6. doi: 10.1016/j.jacr.2013.07.005. Epub 2013 Aug 26. No abstract available.</citation>
    <PMID>23988585</PMID>
  </reference>
  <verification_date>October 30, 2019</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>December 3, 2019</last_update_submitted>
  <last_update_submitted_qc>December 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Volunteer</keyword>
  <keyword>Contrast</keyword>
  <!-- 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/NCT02242448
org study id: 140158
secondary id: 14-CC-0158
nct id: NCT02242448
lead sponsor: 
Background:

      - Computed tomography (CT) scanning is a procedure that helps doctors with diagnoses. It uses
      X-ray radiation to produce an image in three dimensions. Researchers want to study how to get
      the best quality CT scans using the lowest possible radiation dose.

      Objective:

      - To determine how to improve CT scanning.

      Eligibility:

      - Adults 45 years of age and older who have not had a CT scan in the past year and do not
      have kidney disease.

      Design:

        -  Participants will be screened with a medical history and blood and urine tests.

        -  Nurses will put an intravenous (IV) line into an arm or hand vein. It will stay in for
           several hours during the magnetic resonance imaging (MRI) and CT scans. Through this IV,
           blood will be taken, dye will be injected, and medicine will be given.

        -  Participants may have a CT scan of the heart, head, chest, abdomen, and/or pelvis.
           Participants will lie on their back on a table. The table will slide into a donut-shaped
           machine. An X-ray tube will move around the body, taking pictures.

        -  Participants may be given a drug called a beta blocker by mouth or through the IV tube.

        -  Participants heart rate and blood pressure will be monitored.

        -  Participants may have an MRI scan. The MRI is a large hollow tube. The participant will
           lie on a table that will be moved into the tube, which contains a magnetic field. When
           the imaging starts, a thumping sound will be heard. Headphones or earplugs will be
           provided to muffle the sound.

        -  Participants will give blood samples.
In this protocol, computed tomography (CT) imaging performed on healthy volunteers and
      subjects with disease will be used to test, develop and optimize CT protocols. The results of
      this optimization will be used to evaluate the performance of new imaging methods and
      equipment, and to provide essential ground work for research and development for use in
      future patient CT studies. CT imaging is a noninvasive technology. As appropriate, MRI scans
      will be used to compare to CT imaging findings to help validate the CT methods.
observational model: Cohort
time perspective: Prospective
measure: To enhance imaging quality and safety
time frame: ongoing
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David A Bluemke, M.D.
role: Principal Investigator
affiliation: National Institutes of Health Clinical Center (CC)
facility: 
country: United States
citation: Halliburton S, Arbab-Zadeh A, Dey D, Einstein AJ, Gentry R, George RT, Gerber T, Mahesh M, Weigold WG. State-of-the-art in CT hardware and scan modes for cardiovascular CT. J Cardiovasc Comput Tomogr. 2012 May-Jun;6(3):154-63. doi: 10.1016/j.jcct.2012.04.005. Epub 2012 Apr 7.
PMID: 22551595
citation: Trattner S, Pearson GDN, Chin C, Cody DD, Gupta R, Hess CP, Kalra MK, Kofler JM Jr, Krishnam MS, Einstein AJ. Standardization and optimization of CT protocols to achieve low dose. J Am Coll Radiol. 2014 Mar;11(3):271-278. doi: 10.1016/j.jacr.2013.10.016.
PMID: 24589403
citation: Mahesh M. Variability in CT protocols. J Am Coll Radiol. 2013 Oct;10(10):805-6. doi: 10.1016/j.jacr.2013.07.005. Epub 2013 Aug 26. No abstract available.
PMID: 23988585
responsible party type: Sponsor