<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/NCT03028311</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0244</org_study_id>
    <secondary_id>NCI-2017-00629</secondary_id>
    <secondary_id>2016-0244</secondary_id>
    <secondary_id>P30CA016672</secondary_id>
    <nct_id>NCT03028311</nct_id>
  </id_info>
  <brief_title>Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer</brief_title>
  <official_title>Feasibility of Single Session In-Room Yttrium-90 Radioembolization Diagnostic Angiography and Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies the side effects and best way to perform yttrium Y-90&#xD;
      radioembolization in treating patients with liver cancer that has spread to other places in&#xD;
      the body (metastatic). Yttrium Y-90 radioembolization is a therapy that injects radioactive&#xD;
      microspheres directly into an artery that feeds liver tumors to cut off their blood supply.&#xD;
      Performing yttrium Y-90 radioembolization in a single session may make treatment faster,&#xD;
      minimize patient travel, and decrease the overall cost of the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To evaluate the feasibility and safety of same day yttrium-90 radioembolization planning&#xD;
      and treatment angiography.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the patient costs associated with same diagnostic and treatment compared when&#xD;
      compared to the standard two session methodology.&#xD;
&#xD;
      II. To determine the time required to perform the mandatory in-room technetium Tc-99m albumin&#xD;
      aggregated (99mTc-MAA) imaging and the associated calculations for the lung shunt fraction&#xD;
      and treatment 90Y-microsphere activity.&#xD;
&#xD;
      III. To determine the time for delivery of the therapy 90Y-microsphere radioactivity to the&#xD;
      angiography suite after the therapy written directive by the authorized user.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      The first 2 patients enrolled receive standard of care diagnostic and treatment during 2&#xD;
      visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients&#xD;
      undergo diagnostic angiography with embolization of potential hepatoenteric collaterals,&#xD;
      receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via&#xD;
      catheter, and undergo planar imaging. During the second visit, patients undergo a second&#xD;
      angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients&#xD;
      then undergo single-photon emission computed tomography-computed tomography (SPECT-CT)&#xD;
      Bremsstrahlung imaging.&#xD;
&#xD;
      All subsequent patients enrolled undergo the same previously described diagnostic and&#xD;
      treatment during 1 visit over about 8 hours.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 1, 3, and 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success of same day yttrium Y-90 radioembolization planning and treatment angiography</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Success will be defined as treatment dose calculated and patient treated on the same day of initial radiation. Feasibility will be defined as at least 9 successful same day treatments. A procedure lasting greater than 4 hours will be considered a failure. The time associated with various aspects of the same-day yttrium Y-90 radioembolization procedure will be determined. Will determine the time and cost for the patient and for MD Anderson Cancer Center between the same day yttrium Y-90-radioembolization treatment and the current standard of care two-day treatment schedule. Success status will be summarized using frequencies and percentages. Success rate will be estimated along with exact 95% confidence interval. Patient characteristics will be summarized using appropriate summary statistics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The summaries will be overall (severity grades 1 through 5). Actions taken for grade 3 events will also be reported. The summaries will present the number and percentage of patients reporting and adverse event for each classification level as well as the number events reported. Laboratory values will be summarized by the treatment group over time.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Metastatic Liver Carcinoma</condition>
  <condition>Stage IV Liver Cancer</condition>
  <condition>Stage IVA Liver Cancer</condition>
  <condition>Stage IVB Liver Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (angiography, yttrium Y-90 radioembolization)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging.&#xD;
All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Angiography</intervention_name>
    <description>Undergo angiography</description>
    <arm_group_label>Treatment (angiography, yttrium Y-90 radioembolization)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed Tomography</intervention_name>
    <description>Undergo SPECT-CT</description>
    <arm_group_label>Treatment (angiography, yttrium Y-90 radioembolization)</arm_group_label>
    <other_name>CAT</other_name>
    <other_name>CAT Scan</other_name>
    <other_name>Computerized Axial Tomography</other_name>
    <other_name>computerized tomography</other_name>
    <other_name>CT</other_name>
    <other_name>CT SCAN</other_name>
    <other_name>tomography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Planar Imaging</intervention_name>
    <description>Undergo planar imaging</description>
    <arm_group_label>Treatment (angiography, yttrium Y-90 radioembolization)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radioembolization</intervention_name>
    <description>Undergo radioembolization</description>
    <arm_group_label>Treatment (angiography, yttrium Y-90 radioembolization)</arm_group_label>
    <other_name>intra-arterial brachytherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single Photon Emission Computed Tomography</intervention_name>
    <description>Undergo SPECT-CT</description>
    <arm_group_label>Treatment (angiography, yttrium Y-90 radioembolization)</arm_group_label>
    <other_name>Medical Imaging, Single Photon Emission Computed Tomography</other_name>
    <other_name>Single Photon Emission Tomography</other_name>
    <other_name>single-photon emission computed tomography</other_name>
    <other_name>SPECT</other_name>
    <other_name>SPECT imaging</other_name>
    <other_name>SPECT SCAN</other_name>
    <other_name>SPET</other_name>
    <other_name>tomography, emission computed, single photon</other_name>
    <other_name>Tomography, Emission-Computed, Single-Photon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Technetium Tc-99m Albumin Aggregated</intervention_name>
    <description>Given via arterial catheter</description>
    <arm_group_label>Treatment (angiography, yttrium Y-90 radioembolization)</arm_group_label>
    <other_name>Tc 99m-labeled MAA</other_name>
    <other_name>Technetium Tc 99m-Labeled Macroaggregated Albumin</other_name>
    <other_name>Technetium Tc-99m Albumin Colloid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yttrium Y 90 Resin Microspheres</intervention_name>
    <description>Given via arterial catheter</description>
    <arm_group_label>Treatment (angiography, yttrium Y-90 radioembolization)</arm_group_label>
    <other_name>SIR-Spheres</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The ability to understand and sign informed consent&#xD;
&#xD;
          -  Any candidate eligible for standard of care Y90 radioembolization for treatment of&#xD;
             their primary or metastatic liver tumors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with greater than 50% liver tumor burden&#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>Armeen Mahvash</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</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>Liver Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Technetium Tc 99m Aggregated Albumin</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/NCT03028311
org study id: 2016-0244
secondary id: NCI-2017-00629
secondary id: 2016-0244
secondary id: P30CA016672
nct id: NCT03028311
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This clinical trial studies the side effects and best way to perform yttrium Y-90
      radioembolization in treating patients with liver cancer that has spread to other places in
      the body (metastatic). Yttrium Y-90 radioembolization is a therapy that injects radioactive
      microspheres directly into an artery that feeds liver tumors to cut off their blood supply.
      Performing yttrium Y-90 radioembolization in a single session may make treatment faster,
      minimize patient travel, and decrease the overall cost of the procedure.
PRIMARY OBJECTIVE:

      I. To evaluate the feasibility and safety of same day yttrium-90 radioembolization planning
      and treatment angiography.

      SECONDARY OBJECTIVES:

      I. To determine the patient costs associated with same diagnostic and treatment compared when
      compared to the standard two session methodology.

      II. To determine the time required to perform the mandatory in-room technetium Tc-99m albumin
      aggregated (99mTc-MAA) imaging and the associated calculations for the lung shunt fraction
      and treatment 90Y-microsphere activity.

      III. To determine the time for delivery of the therapy 90Y-microsphere radioactivity to the
      angiography suite after the therapy written directive by the authorized user.

      OUTLINE:

      The first 2 patients enrolled receive standard of care diagnostic and treatment during 2
      visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients
      undergo diagnostic angiography with embolization of potential hepatoenteric collaterals,
      receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via
      catheter, and undergo planar imaging. During the second visit, patients undergo a second
      angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients
      then undergo single-photon emission computed tomography-computed tomography (SPECT-CT)
      Bremsstrahlung imaging.

      All subsequent patients enrolled undergo the same previously described diagnostic and
      treatment during 1 visit over about 8 hours.

      After completion of study treatment, patients are followed up at 1, 3, and 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Success of same day yttrium Y-90 radioembolization planning and treatment angiography
time frame: Up to 6 months
description: Success will be defined as treatment dose calculated and patient treated on the same day of initial radiation. Feasibility will be defined as at least 9 successful same day treatments. A procedure lasting greater than 4 hours will be considered a failure. The time associated with various aspects of the same-day yttrium Y-90 radioembolization procedure will be determined. Will determine the time and cost for the patient and for MD Anderson Cancer Center between the same day yttrium Y-90-radioembolization treatment and the current standard of care two-day treatment schedule. Success status will be summarized using frequencies and percentages. Success rate will be estimated along with exact 95% confidence interval. Patient characteristics will be summarized using appropriate summary statistics.
measure: Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
time frame: Up to 6 months
description: The summaries will be overall (severity grades 1 through 5). Actions taken for grade 3 events will also be reported. The summaries will present the number and percentage of patients reporting and adverse event for each classification level as well as the number events reported. Laboratory values will be summarized by the treatment group over time.
arm group label: Treatment (angiography, yttrium Y-90 radioembolization)
arm group type: Other
description: The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging.
All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours.
intervention type: Procedure
intervention name: Angiography
description: Undergo angiography
arm group label: Treatment (angiography, yttrium Y-90 radioembolization)
intervention type: Procedure
intervention name: Computed Tomography
description: Undergo SPECT-CT
arm group label: Treatment (angiography, yttrium Y-90 radioembolization)
other name: CAT
other name: CAT Scan
other name: Computerized Axial Tomography
other name: computerized tomography
other name: CT
other name: CT SCAN
other name: tomography
intervention type: Procedure
intervention name: Planar Imaging
description: Undergo planar imaging
arm group label: Treatment (angiography, yttrium Y-90 radioembolization)
intervention type: Radiation
intervention name: Radioembolization
description: Undergo radioembolization
arm group label: Treatment (angiography, yttrium Y-90 radioembolization)
other name: intra-arterial brachytherapy
intervention type: Procedure
intervention name: Single Photon Emission Computed Tomography
description: Undergo SPECT-CT
arm group label: Treatment (angiography, yttrium Y-90 radioembolization)
other name: Medical Imaging, Single Photon Emission Computed Tomography
other name: Single Photon Emission Tomography
other name: single-photon emission computed tomography
other name: SPECT
other name: SPECT imaging
other name: SPECT SCAN
other name: SPET
other name: tomography, emission computed, single photon
other name: Tomography, Emission-Computed, Single-Photon
intervention type: Radiation
intervention name: Technetium Tc-99m Albumin Aggregated
description: Given via arterial catheter
arm group label: Treatment (angiography, yttrium Y-90 radioembolization)
other name: Tc 99m-labeled MAA
other name: Technetium Tc 99m-Labeled Macroaggregated Albumin
other name: Technetium Tc-99m Albumin Colloid
intervention type: Other
intervention name: Yttrium Y 90 Resin Microspheres
description: Given via arterial catheter
arm group label: Treatment (angiography, yttrium Y-90 radioembolization)
other name: SIR-Spheres
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Armeen Mahvash
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Liver Neoplasms
mesh term: Carcinoma, Hepatocellular
mesh term: Technetium Tc 99m Aggregated Albumin