<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/NCT03761121</url>
  </required_header>
  <id_info>
    <org_study_id>18-325</org_study_id>
    <secondary_id>R01EB020613</secondary_id>
    <nct_id>NCT03761121</nct_id>
  </id_info>
  <brief_title>Developing Fast Pediatric Imaging</brief_title>
  <official_title>Developing Fast Pediatric Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Biomedical Imaging and Bioengineering (NIBIB)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is evaluating the investigational software for magnetic resonance imaging&#xD;
      (MRI) systems and techniques to process magnetic resonance (MR) images&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to develop new technologies for MRI systems. The new technologies&#xD;
      should improve MRI capabilities in terms of how sensitive, specific, and efficient they are.&#xD;
      The overall goal is to get better measurements of the brain tumor tissue(s).&#xD;
&#xD;
      In this research study, the investigators want to learn more about investigational software&#xD;
      and about techniques to process MR images. The testing of investigational software will allow&#xD;
      the investigators to improve the image quality. As part of the testing process, the&#xD;
      investigators will collect more MR images of the brain, and improve current image&#xD;
      reconstruction methods. This will allow a more precise analysis of MR images and potentially&#xD;
      better assessment of the brain tumor tissue volume.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wave-CAIPI validation</measure>
    <time_frame>2 years</time_frame>
    <description>The outcome measure for this project will be that the rapid scan from Wave-CAIPI can provide equivalent diagnostic quality to that of standard clinical acquisitions which is performed at much slower speed. This will be assess using visual qualitative assessment by experienced radiologists on the project.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Pediatric Low-grade Gliomas</condition>
  <arm_group>
    <arm_group_label>Primary Testing Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This scan is in the same imaging session as the participant's scheduled clinical MRI and is no longer 15 minutes&#xD;
Wave-CAIPI will be use to enable a 40-60 s acquisition per contrast at 0.9-mm isotropic resolution&#xD;
Wave-CAIPI will be used to acquire a 4-echo GE-SE time-series at 1.5-mm isotropic resolution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Software Testing Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive hour research-only scan&#xD;
Wave-CAIPI will be use to enable a 40-60 s acquisition per contrast at 0.9-mm isotropic resolution&#xD;
Wave-CAIPI will be used to acquire a 4-echo GE-SE time-series at 1.5-mm isotropic resolution</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wave-CAIPI</intervention_name>
    <description>&quot;wave-CAIPI&quot; technology, a data acquisition / reconstruction scheme designed to optimally exploit available information in modern multi-channel receivers and in multi-contrast/time-series data for improved image encoding</description>
    <arm_group_label>Primary Testing Group</arm_group_label>
    <arm_group_label>Software Testing Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants, children and adults who have been diagnosed with Low Grade Glioma&#xD;
&#xD;
          -  Healthy volunteers - Children from age 0 to adults with no upper age limit or;&#xD;
&#xD;
          -  Diagnosed with LGG and being treated at DFCI;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Electrical implants such as cardiac pacemakers or perfusion pumps;&#xD;
&#xD;
          -  Ferromagnetic implants such as aneurysm clips, surgical clips, prosthesis, artificial&#xD;
             hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or&#xD;
             steel implants;&#xD;
&#xD;
          -  Ferromagnetic objects such as jewelry or metal clips;&#xD;
&#xD;
          -  Women of childbearing age who are seeking to become pregnant, who are breastfeeding,&#xD;
             or who suspect they may be pregnant;&#xD;
&#xD;
          -  Pre-existing medical conditions including a likelihood of developing seizures or&#xD;
             claustrophobic reactions;&#xD;
&#xD;
          -  Any greater than normal potential for cardiac arrest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kawin Setsompop, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children Hospital/ Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kawin Setsompop, PhD</last_name>
    <phone>617-669-6640</phone>
    <email>kawin@nmr.mgh.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02214</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kawin Setsompop, PhD</last_name>
      <phone>617-669-6640</phone>
      <email>kawin@nmr.mgh.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Kawin Setsompop, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Boston Children Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan N Chi, MD</last_name>
      <phone>617-632-3000</phone>
      <email>schi@partners.org</email>
    </contact>
    <investigator>
      <last_name>Susan N Chi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan N Chi, MD</last_name>
      <phone>617-632-3000</phone>
      <email>schi@partners.org</email>
    </contact>
    <investigator>
      <last_name>Susan N Chi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Ellen Grant</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Neuro Oncology</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication.</ipd_time_frame>
    <ipd_access_criteria>Requests may be directed to: [contact information for Sponsor- Investigator or designee].</ipd_access_criteria>
  </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/NCT03761121
org study id: 18-325
secondary id: R01EB020613
nct id: NCT03761121
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This research study is evaluating the investigational software for magnetic resonance imaging
      (MRI) systems and techniques to process magnetic resonance (MR) images
The purpose of the study is to develop new technologies for MRI systems. The new technologies
      should improve MRI capabilities in terms of how sensitive, specific, and efficient they are.
      The overall goal is to get better measurements of the brain tumor tissue(s).

      In this research study, the investigators want to learn more about investigational software
      and about techniques to process MR images. The testing of investigational software will allow
      the investigators to improve the image quality. As part of the testing process, the
      investigators will collect more MR images of the brain, and improve current image
      reconstruction methods. This will allow a more precise analysis of MR images and potentially
      better assessment of the brain tumor tissue volume.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Wave-CAIPI validation
time frame: 2 years
description: The outcome measure for this project will be that the rapid scan from Wave-CAIPI can provide equivalent diagnostic quality to that of standard clinical acquisitions which is performed at much slower speed. This will be assess using visual qualitative assessment by experienced radiologists on the project.
arm group label: Primary Testing Group
arm group type: Experimental
description: This scan is in the same imaging session as the participant's scheduled clinical MRI and is no longer 15 minutes
Wave-CAIPI will be use to enable a 40-60 s acquisition per contrast at 0.9-mm isotropic resolution
Wave-CAIPI will be used to acquire a 4-echo GE-SE time-series at 1.5-mm isotropic resolution
arm group label: Software Testing Group
arm group type: Experimental
description: Participants will receive hour research-only scan
Wave-CAIPI will be use to enable a 40-60 s acquisition per contrast at 0.9-mm isotropic resolution
Wave-CAIPI will be used to acquire a 4-echo GE-SE time-series at 1.5-mm isotropic resolution
intervention type: Other
intervention name: Wave-CAIPI
description: "wave-CAIPI" technology, a data acquisition / reconstruction scheme designed to optimally exploit available information in modern multi-channel receivers and in multi-contrast/time-series data for improved image encoding
arm group label: Primary Testing Group
arm group label: Software Testing Group
criteria: 
gender: All
minimum age: 0 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kawin Setsompop, PhD
role: Principal Investigator
affiliation: Boston Children Hospital/ Massachusetts General Hospital
last name: Kawin Setsompop, PhD
phone: 617-669-6640
email: kawin@nmr.mgh.harvard.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Ellen Grant
investigator title: Principal Investigator
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication.
ipd access criteria: Requests may be directed to: [contact information for Sponsor- Investigator or designee].