<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/NCT02967380</url>
  </required_header>
  <id_info>
    <org_study_id>0S-11-6</org_study_id>
    <secondary_id>NCI-2014-01852</secondary_id>
    <secondary_id>D1 2010-10</secondary_id>
    <secondary_id>HS-11-00363</secondary_id>
    <secondary_id>0S-11-6</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT02967380</nct_id>
  </id_info>
  <brief_title>Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases</brief_title>
  <official_title>Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial compares gadobutrol with standard of care contrast agents,&#xD;
      gadopentetate dimeglumine or gadobenate dimeglumine, before dynamic contrast-enhanced&#xD;
      (DCE)-magnetic resonance imaging (MRI) in diagnosing patients with multiple sclerosis, grade&#xD;
      II-IV glioma, or tumors that have spread to the brain. Gadobutrol is a type of contrast agent&#xD;
      that may increase DCE-MRI sensitivity for the detection of tumors or other diseases of the&#xD;
      central nervous system. It is not yet known whether gadobutrol is more effective than&#xD;
      standard of care contrast agents before DCE-MRI in diagnosing patients with multiple&#xD;
      sclerosis, grade II-IV glioma, or tumors that have spread to the brain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine whether Gadavist® (gadobutrol) is consistent with Magnevist® (gadopentetate&#xD;
      dimeglumine) or Multihance (gadobenate dimeglumine) in the preoperative grading of gliomas&#xD;
      utilizing DCE MRI.&#xD;
&#xD;
      II. To determine whether Gadavist® is consistent with Magnevist® or Multihance in identifying&#xD;
      the number of cerebral metastases from a primary cancer elsewhere in the body using&#xD;
      T1-weighted post contrast MRI.&#xD;
&#xD;
      III. To determine if Gadavist® is consistent with Magnevist® or Multihance in identifying&#xD;
      multiple sclerosis (MS) plaques using T1-weighted post contrast MRI.&#xD;
&#xD;
      IV. To determine if Gadavist® produces similar MR perfusion/permeability values of MS lesions&#xD;
      as Magnevist® or Multihance.&#xD;
&#xD;
      V. Descriptive analysis to present the different rating patterns of Gadavist® versus&#xD;
      Magnevist® or Multihance in differentiating therapeutic necrosis from recurrent tumor in&#xD;
      gliomas utilizing DCE MRI.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive standard of care gadopentetate dimeglumine intravenously (IV) twice within 5&#xD;
      minutes or gadobenate dimeglumine IV twice within 5 minutes and then undergo DCE-MRI on day&#xD;
      1. Patients also receive gadobutrol IV twice within 5 minutes and then undergo DCE-MRI over&#xD;
      approximately 30 minutes on day 3, 4, 5, 6, or 7.&#xD;
&#xD;
      After completion of study, patients are followed up at 7 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient Accrual&#xD;
  </why_stopped>
  <start_date type="Actual">December 14, 2011</start_date>
  <completion_date type="Actual">October 14, 2015</completion_date>
  <primary_completion_date type="Actual">October 14, 2014</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>Agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Weighted Kappa analysis will be used to examine the agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Adult Anaplastic (Malignant) Meningioma</condition>
  <condition>Adult Anaplastic Astrocytoma</condition>
  <condition>Adult Anaplastic Ependymoma</condition>
  <condition>Adult Anaplastic Oligodendroglioma</condition>
  <condition>Adult Brain Stem Glioma</condition>
  <condition>Adult Choroid Plexus Neoplasm</condition>
  <condition>Adult Diffuse Astrocytoma</condition>
  <condition>Adult Ependymoblastoma</condition>
  <condition>Adult Ependymoma</condition>
  <condition>Adult Giant Cell Glioblastoma</condition>
  <condition>Adult Glioblastoma</condition>
  <condition>Adult Gliosarcoma</condition>
  <condition>Adult Grade II Meningioma</condition>
  <condition>Adult Medulloblastoma</condition>
  <condition>Adult Mixed Glioma</condition>
  <condition>Adult Oligodendroglioma</condition>
  <condition>Adult Papillary Meningioma</condition>
  <condition>Adult Pineal Gland Astrocytoma</condition>
  <condition>Adult Pineoblastoma</condition>
  <condition>Adult Primary Melanocytic Lesion of Meninges</condition>
  <condition>Adult Supratentorial Primitive Neuroectodermal Tumor</condition>
  <condition>Malignant Adult Intracranial Hemangiopericytoma</condition>
  <condition>Metastatic Malignant Neoplasm in the Brain</condition>
  <condition>Multiple Sclerosis</condition>
  <condition>Recurrent Adult Brain Neoplasm</condition>
  <arm_group>
    <arm_group_label>Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive standard of care gadopentetate dimeglumine IV twice within 5 minutes or gadobenate dimeglumine IV twice within 5 minutes and then undergo DCE-MRI on day 1. Patients also receive gadobutrol IV twice within 5 minutes and then undergo DCE-MRI over approximately 30 minutes on day 3, 4, 5, 6, or 7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dynamic Contrast-Enhanced Magnetic Resonance Imaging</intervention_name>
    <description>Undergo DCE-MRI</description>
    <arm_group_label>Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)</arm_group_label>
    <other_name>DCE MRI</other_name>
    <other_name>DCE-MRI</other_name>
    <other_name>DYNAMIC CONTRAST ENHANCED MRI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gadobenate Dimeglumine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)</arm_group_label>
    <other_name>Gd-BOPTA</other_name>
    <other_name>MultiHance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gadobutrol</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)</arm_group_label>
    <other_name>BAY86-4875</other_name>
    <other_name>Gadograf</other_name>
    <other_name>Gadovist</other_name>
    <other_name>Protovis</other_name>
    <other_name>ZK 135079</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Gadopentetate Dimeglumine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)</arm_group_label>
    <other_name>Gadolinium DTPA</other_name>
    <other_name>Gd-DTPA</other_name>
    <other_name>Magnevist</other_name>
    <other_name>Meglumine Gadopentetate</other_name>
    <other_name>SH L 451 A</other_name>
    <other_name>ZK 93035</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of multiple sclerosis, known or suspected diagnosis of glioma, or&#xD;
             known or suspected diagnosis of cerebral metastasis&#xD;
&#xD;
          -  Scheduled or to be scheduled for a follow-up MRI per standard of care for their&#xD;
             disease&#xD;
&#xD;
          -  Minimum permitted time intervals from prior treatments are 6 weeks for intracranial&#xD;
             surgery&#xD;
&#xD;
          -  Adequate renal function (serum creatinine =&lt; 1.5 mg/dL)&#xD;
&#xD;
          -  Subject must sign a study-specific informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically unstable&#xD;
&#xD;
          -  Renal impairment (glomerular filtration rate [GFR] &lt; 60 mL/min/1.73m^2) or history of&#xD;
             existing nephrogenic systemic fibrosis (NSF)&#xD;
&#xD;
          -  Cardiac pacemaker&#xD;
&#xD;
          -  A serious concurrent infection, illness, or medical condition&#xD;
&#xD;
          -  Subjects with any surgical clip, external clips, or any other ferromagnetic device,&#xD;
             that is contraindicated for use in MRI&#xD;
&#xD;
          -  Subject is claustrophobic and cannot cooperate for the MRI&#xD;
&#xD;
          -  Females who are pregnant or nursing&#xD;
&#xD;
          -  Any other condition that would compromise the scan with reasonable safety&#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>Meng Law</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 13, 2015</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>March 22, 2017</last_update_submitted>
  <last_update_submitted_qc>March 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Glioma</mesh_term>
    <mesh_term>Astrocytoma</mesh_term>
    <mesh_term>Meningioma</mesh_term>
    <mesh_term>Ependymoma</mesh_term>
    <mesh_term>Gliosarcoma</mesh_term>
    <mesh_term>Medulloblastoma</mesh_term>
    <mesh_term>Oligodendroglioma</mesh_term>
    <mesh_term>Neuroectodermal Tumors</mesh_term>
    <mesh_term>Neuroectodermal Tumors, Primitive</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Pinealoma</mesh_term>
    <mesh_term>Hemangiopericytoma</mesh_term>
    <mesh_term>Solitary Fibrous Tumors</mesh_term>
    <mesh_term>Choroid Plexus Neoplasms</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pentetic Acid</mesh_term>
  </intervention_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/NCT02967380
org study id: 0S-11-6
secondary id: NCI-2014-01852
secondary id: D1 2010-10
secondary id: HS-11-00363
secondary id: 0S-11-6
secondary id: P30CA014089
nct id: NCT02967380
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pilot clinical trial compares gadobutrol with standard of care contrast agents,
      gadopentetate dimeglumine or gadobenate dimeglumine, before dynamic contrast-enhanced
      (DCE)-magnetic resonance imaging (MRI) in diagnosing patients with multiple sclerosis, grade
      II-IV glioma, or tumors that have spread to the brain. Gadobutrol is a type of contrast agent
      that may increase DCE-MRI sensitivity for the detection of tumors or other diseases of the
      central nervous system. It is not yet known whether gadobutrol is more effective than
      standard of care contrast agents before DCE-MRI in diagnosing patients with multiple
      sclerosis, grade II-IV glioma, or tumors that have spread to the brain.
PRIMARY OBJECTIVES:

      I. To determine whether Gadavist® (gadobutrol) is consistent with Magnevist® (gadopentetate
      dimeglumine) or Multihance (gadobenate dimeglumine) in the preoperative grading of gliomas
      utilizing DCE MRI.

      II. To determine whether Gadavist® is consistent with Magnevist® or Multihance in identifying
      the number of cerebral metastases from a primary cancer elsewhere in the body using
      T1-weighted post contrast MRI.

      III. To determine if Gadavist® is consistent with Magnevist® or Multihance in identifying
      multiple sclerosis (MS) plaques using T1-weighted post contrast MRI.

      IV. To determine if Gadavist® produces similar MR perfusion/permeability values of MS lesions
      as Magnevist® or Multihance.

      V. Descriptive analysis to present the different rating patterns of Gadavist® versus
      Magnevist® or Multihance in differentiating therapeutic necrosis from recurrent tumor in
      gliomas utilizing DCE MRI.

      OUTLINE:

      Patients receive standard of care gadopentetate dimeglumine intravenously (IV) twice within 5
      minutes or gadobenate dimeglumine IV twice within 5 minutes and then undergo DCE-MRI on day
      1. Patients also receive gadobutrol IV twice within 5 minutes and then undergo DCE-MRI over
      approximately 30 minutes on day 3, 4, 5, 6, or 7.

      After completion of study, patients are followed up at 7 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading
time frame: Up to 7 days
description: Weighted Kappa analysis will be used to examine the agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading.
arm group label: Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
arm group type: Experimental
description: Patients receive standard of care gadopentetate dimeglumine IV twice within 5 minutes or gadobenate dimeglumine IV twice within 5 minutes and then undergo DCE-MRI on day 1. Patients also receive gadobutrol IV twice within 5 minutes and then undergo DCE-MRI over approximately 30 minutes on day 3, 4, 5, 6, or 7.
intervention type: Procedure
intervention name: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
description: Undergo DCE-MRI
arm group label: Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
other name: DCE MRI
other name: DCE-MRI
other name: DYNAMIC CONTRAST ENHANCED MRI
intervention type: Drug
intervention name: Gadobenate Dimeglumine
description: Given IV
arm group label: Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
other name: Gd-BOPTA
other name: MultiHance
intervention type: Drug
intervention name: Gadobutrol
description: Given IV
arm group label: Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
other name: BAY86-4875
other name: Gadograf
other name: Gadovist
other name: Protovis
other name: ZK 135079
intervention type: Radiation
intervention name: Gadopentetate Dimeglumine
description: Given IV
arm group label: Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
other name: Gadolinium DTPA
other name: Gd-DTPA
other name: Magnevist
other name: Meglumine Gadopentetate
other name: SH L 451 A
other name: ZK 93035
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Meng Law
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Glioblastoma
mesh term: Glioma
mesh term: Astrocytoma
mesh term: Meningioma
mesh term: Ependymoma
mesh term: Gliosarcoma
mesh term: Medulloblastoma
mesh term: Oligodendroglioma
mesh term: Neuroectodermal Tumors
mesh term: Neuroectodermal Tumors, Primitive
mesh term: Brain Neoplasms
mesh term: Pinealoma
mesh term: Hemangiopericytoma
mesh term: Solitary Fibrous Tumors
mesh term: Choroid Plexus Neoplasms
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Pentetic Acid