<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/NCT04427384</url>
  </required_header>
  <id_info>
    <org_study_id>GTM-101</org_study_id>
    <nct_id>NCT04427384</nct_id>
  </id_info>
  <brief_title>Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)</brief_title>
  <official_title>A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GT Medical Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GT Medical Technologies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this registry study are to evaluate real-world clinical outcomes and&#xD;
      patient reported outcomes that measure the effectiveness and safety of STaRT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients (N=600) with surgically resected (R) brain tumors of any pathology who have&#xD;
      undergone STaRT are eligible. Data collected will include local control, overall survival,&#xD;
      QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data&#xD;
      will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years.&#xD;
      RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for&#xD;
      comparisons to existing standard-of-care treatments. This will be the first observational&#xD;
      registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable&#xD;
      collagen tile carriers. The outcome measures captured will allow for evaluation of the&#xD;
      potential risks and benefits of this treatment approach for patients in a real-world setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 11, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2028</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects</measure>
    <time_frame>12 months</time_frame>
    <description>No contrast enhancement in the area of the surgical bed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects</measure>
    <time_frame>3 years</time_frame>
    <description>No contrast enhancement in the area of the surgical bed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival in High Grade Glioma Subjects</measure>
    <time_frame>9 months</time_frame>
    <description>Median duration of survival of subjects following surgical resection of tumor</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Brain Tumor, Recurrent</condition>
  <condition>Brain Tumor</condition>
  <condition>Brain Tumor, Primary</condition>
  <condition>Brain Tumor - Metastatic</condition>
  <condition>Brain Tumor, Adult: Glioblastoma</condition>
  <condition>Brain Tumor, Adult Meningioma</condition>
  <arm_group>
    <arm_group_label>GammaTile</arm_group_label>
    <description>Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GammaTile</intervention_name>
    <description>Surgically Targeted Radiation Therapy</description>
    <arm_group_label>GammaTile</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who received STaRT intraoperatively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND&#xD;
             implantation of GammaTiles.&#xD;
&#xD;
          2. Willing and able to provide informed consent and to participate in all evaluations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to undergo pre-operative and post-operative imaging for disease and implant&#xD;
             assessment.&#xD;
&#xD;
          2. Major medical or psychiatric illness, which, in the investigator's opinion would&#xD;
             prevent completion of treatment, ability to complete assessments at the time of&#xD;
             enrollment, and/or interfere with follow ups.&#xD;
&#xD;
          3. Lack of English language fluency sufficient to allow for completion of neurocognitive&#xD;
             and QOL tests (which are in English).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Campbell, PhD GT Medical Technologies</last_name>
    <role>Study Director</role>
    <affiliation>GT Medical Technologies</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa Campbell, PhD GT Medical Technologies</last_name>
    <phone>(833) 662-0044</phone>
    <email>lcampbell@gtmedtech.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Angela Hall GT Medical Technologies</last_name>
    <email>ahall@gtmedtech.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>HonorHealth Research Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Wanebo, MD</last_name>
    </contact>
    <investigator>
      <last_name>John Wanebo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Arkansas Medical Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Analiz Rodriguez, MD, PhD</last_name>
      <phone>501-296-1138</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>UCSD Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Piccioni, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>David Piccioni, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sutter health</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lewis Leng, MD</last_name>
      <phone>415-600-0528</phone>
    </contact>
    <investigator>
      <last_name>Lewis Leng, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centura</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Angela Bohnen, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Colorado Brain &amp; Spine Institute: Swedish Campus</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vadim Tsvankin, MD</last_name>
      <phone>303-783-8844</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>BayCare Health</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Devon Haydon, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute, Baptist Health South Florida</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rupesh Kotecha, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Orlando Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Mercado, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tulika Ranjan, MD</last_name>
    </contact>
    <contact_backup>
      <phone>813-844-7585</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Florida- Weston</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Surabhi Ranjan, MD, FACP</last_name>
      <phone>954-659-5670</phone>
    </contact>
    <investigator>
      <last_name>Surabhi Ranjan, MD, FACP</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Piedmont Healthcare</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adam Nowlan, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute of Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kimberly Bojanowski</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Alphonsus Regional Medical Center</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83704</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ondrej Choutka</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Indiana University, IU Health Methodist Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mitesh Shah</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>KUMC Dept of Neurosurgery</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kushal Shah</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Parag Sevak, MD</last_name>
      <email>Parag.Sevak@nortonhealthcare.org</email>
    </contact>
    <investigator>
      <last_name>Parag Sevak, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Willis-Knighton Medical Center</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adam M Robin, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Trusheim, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55414</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clark Chen, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Nebraska</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michele Aizenberg, MD</last_name>
      <phone>402-559-6704</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Research dep. Davison Place. Englewood Health</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kevin Yao, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Dubin David, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Westchester Medical Center</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simon Hanft</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of North Carolina Health</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colette Shen, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vidant</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stuart Lee, MD</last_name>
      <phone>252-847-1550</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mayfield Brain and Spine</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent DiNapoli, MD</last_name>
      <phone>513-888-7564</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kettering Health</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Hoeprich, MD</last_name>
      <phone>937-298-4331</phone>
    </contact>
    <investigator>
      <last_name>Mark Hoeprich, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St Luke's University Health, Sacred Heart Campus</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nimisha Deb, MD</last_name>
      <phone>484-503-4418</phone>
      <email>Nimisha.Deb@sluhn.org</email>
    </contact>
    <investigator>
      <last_name>Nimisha Deb, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Simmons Cancer Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Toral Patel, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baylor St. Luke's Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Akash Patel, MD</last_name>
      <phone>713-798-8810</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Methodist Hospital Research Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Baskin, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Floyd, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-The Woodlands</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77380</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Zhu, M.D., Ph.D.</last_name>
      <email>james.zhu@usoncology.com</email>
    </contact>
    <investigator>
      <last_name>James Zhu, M.D., Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Mason</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huong Pham, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 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>Neoplasms</mesh_term>
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Meningioma</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/NCT04427384
org study id: GTM-101
nct id: NCT04427384
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objectives of this registry study are to evaluate real-world clinical outcomes and
      patient reported outcomes that measure the effectiveness and safety of STaRT.
Patients (N=600) with surgically resected (R) brain tumors of any pathology who have
      undergone STaRT are eligible. Data collected will include local control, overall survival,
      QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data
      will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years.
      RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for
      comparisons to existing standard-of-care treatments. This will be the first observational
      registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable
      collagen tile carriers. The outcome measures captured will allow for evaluation of the
      potential risks and benefits of this treatment approach for patients in a real-world setting.
observational model: Cohort
time perspective: Prospective
measure: Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects
time frame: 12 months
description: No contrast enhancement in the area of the surgical bed
measure: Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects
time frame: 3 years
description: No contrast enhancement in the area of the surgical bed
measure: Overall Survival in High Grade Glioma Subjects
time frame: 9 months
description: Median duration of survival of subjects following surgical resection of tumor
arm group label: GammaTile
description: Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.
intervention type: Device
intervention name: GammaTile
description: Surgically Targeted Radiation Therapy
arm group label: GammaTile
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lisa Campbell, PhD GT Medical Technologies
role: Study Director
affiliation: GT Medical Technologies
last name: Lisa Campbell, PhD GT Medical Technologies
phone: (833) 662-0044
email: lcampbell@gtmedtech.com
last name: Angela Hall GT Medical Technologies
email: ahall@gtmedtech.com
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country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Glioblastoma
mesh term: Brain Neoplasms
mesh term: Meningioma
sharing ipd: No