<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/NCT04452162</url>
  </required_header>
  <id_info>
    <org_study_id>25319</org_study_id>
    <secondary_id>834242</secondary_id>
    <nct_id>NCT04452162</nct_id>
  </id_info>
  <brief_title>Physiologic MR Imaging of Salivary Gland Tumors</brief_title>
  <acronym>PSGT</acronym>
  <official_title>Physiologic MR Imaging in Distinguishing Benign From Malignant Salivary Gland Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abramson Cancer Center at Penn Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>McCabe Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Abramson Cancer Center at Penn Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to use advanced Magnetic Resonance Imaging (MRI) techniques to help&#xD;
      identify the difference between cancerous and non-cancerous salivary gland tumors for&#xD;
      improving treatment strategies and to aid in the prediction of disease progression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this proposed study is to investigate the potential utility of combined analysis&#xD;
      of parameters (Ktrans, ti and ADC) in discriminating benign from malignant salivary glands&#xD;
      tumors (SGTs). A total of 30 treatment naïve patients suspicious of SGT as observed on&#xD;
      clinical evaluation and prior routine CT, MRI, Ultrasound, FNAC and/or PET will undergo 3T&#xD;
      MRI. The MRI protocol will include acquisition of anatomical images with and without contrast&#xD;
      agent injection, diffusion imaging and dynamic contrast enhanced-MRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>N/A</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>Differentiation and Progression Free</measure>
    <time_frame>6 Month after the end of treatment</time_frame>
    <description>Differentiation of malignant from benign neoplasms and progression free survival at 6 month starting from end of chemo-radiation treatment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Salivary Gland Tumor</condition>
  <arm_group>
    <arm_group_label>Salivary Gland Tumor</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>You are being asked to complete one research MRI scan with and without contrast since your most recent clinical evaluation and/or prior imaging has shown the presence of a suspicious salivary gland tumor, prior to your scheduled upcoming surgery. MRI contrast agents act like a dye to make MRI pictures brighter and easier to read. During each MRI scan, you will have an intravenous line (IV line) placed. The IV line allows the contrast agent to be injected into your vein. If you have a history of renal disease you may be asked to complete a blood draw of approximately 2.5cc (½ teaspoon), for glomerular filtration rate (GFR) assessment for participation into the study.</description>
    <arm_group_label>Salivary Gland Tumor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Possess a salivary gland lesion of 1cm3 size&#xD;
&#xD;
          -  Have no prior history of treatment for salivary gland lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has any prior history of cancer other than SGT&#xD;
&#xD;
          -  Has any MRI contra-indications&#xD;
&#xD;
          -  Has a history of known renal disease.&#xD;
&#xD;
          -  Has history of prior radiation to head and neck region&#xD;
&#xD;
          -  Is pregnant&#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>Sanjeev Chawla</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marisa Sanchez</last_name>
    <phone>2159019994</phone>
    <email>Marisa.Sanchez@pennmedicine.upenn.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lisa Desiderio</last_name>
    <phone>610-721-3365</phone>
    <email>lisa.desiderio@pennmedicine.upenn.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marisa Sanchez</last_name>
      <email>Marisa.Sanchez@pennmedicine.upenn.edu</email>
    </contact>
    <contact_backup>
      <last_name>Leeanne Lezotte</last_name>
      <phone>856-364-3137</phone>
      <email>leeanne.lezotte@pennmedicine.upenn.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Sanjeev Chawla</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Sanjeev Chawla</investigator_full_name>
    <investigator_title>Assistant Research Professor of Radiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salivary Gland Neoplasms</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/NCT04452162
org study id: 25319
secondary id: 834242
nct id: NCT04452162
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to use advanced Magnetic Resonance Imaging (MRI) techniques to help
      identify the difference between cancerous and non-cancerous salivary gland tumors for
      improving treatment strategies and to aid in the prediction of disease progression.
The goal of this proposed study is to investigate the potential utility of combined analysis
      of parameters (Ktrans, ti and ADC) in discriminating benign from malignant salivary glands
      tumors (SGTs). A total of 30 treatment naïve patients suspicious of SGT as observed on
      clinical evaluation and prior routine CT, MRI, Ultrasound, FNAC and/or PET will undergo 3T
      MRI. The MRI protocol will include acquisition of anatomical images with and without contrast
      agent injection, diffusion imaging and dynamic contrast enhanced-MRI.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Differentiation and Progression Free
time frame: 6 Month after the end of treatment
description: Differentiation of malignant from benign neoplasms and progression free survival at 6 month starting from end of chemo-radiation treatment
arm group label: Salivary Gland Tumor
arm group type: Other
intervention type: Diagnostic Test
intervention name: MRI
description: You are being asked to complete one research MRI scan with and without contrast since your most recent clinical evaluation and/or prior imaging has shown the presence of a suspicious salivary gland tumor, prior to your scheduled upcoming surgery. MRI contrast agents act like a dye to make MRI pictures brighter and easier to read. During each MRI scan, you will have an intravenous line (IV line) placed. The IV line allows the contrast agent to be injected into your vein. If you have a history of renal disease you may be asked to complete a blood draw of approximately 2.5cc (½ teaspoon), for glomerular filtration rate (GFR) assessment for participation into the study.
arm group label: Salivary Gland Tumor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sanjeev Chawla
role: Principal Investigator
affiliation: Professor
last name: Marisa Sanchez
phone: 2159019994
email: Marisa.Sanchez@pennmedicine.upenn.edu
last name: Lisa Desiderio
phone: 610-721-3365
email: lisa.desiderio@pennmedicine.upenn.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Sanjeev Chawla
investigator title: Assistant Research Professor of Radiology
mesh term: Salivary Gland Neoplasms
sharing ipd: No