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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GammaTile | Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GammaTile | Device | Surgically Targeted Radiation Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects | No contrast enhancement in the area of the surgical bed | 12 months |
| Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects | No contrast enhancement in the area of the surgical bed | 3 years |
| Overall Survival in High Grade Glioma Subjects | Median duration of survival of subjects following surgical resection of tumor | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who received STaRT (GammaTile) intraoperatively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael A. Garcia, MD, MS | Contact | (833) 662-0044 | mgarcia@gtmedtech.com | |
| Sita Patel, PhD, PharmD | Contact | (833)662-0044 | spatel@gtmedtech.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael A. Garcia, MD, MS | GT Medical Technologies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHeath Scottsdale Osborn Medical Center | Recruiting | Phoenix | Arizona | 85027 | United States |
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| University of Arkansas Medical Center | Recruiting | Little Rock | Arkansas | 72205 | United States |
|
| Eden Medical Center | Recruiting | Castro Valley | California | 94546 | United States |
|
| UCSD Moores Cancer Center | Recruiting | La Jolla | California | 92093 | United States |
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| MemorialCare Health System | Recruiting | Laguna Hills | California | 92653 | United States |
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| Desert Regional Medical Center | Recruiting | Palm Springs | California | 92262 | United States |
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| California Pacific Medical Center, Sutter health | Recruiting | San Francisco | California | 94109 | United States |
|
| Centura | Not yet recruiting | Denver | Colorado | 80201 | United States |
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| Colorado Brain & Spine Institute: Swedish Campus | Recruiting | Englewood | Colorado | 80113 | United States |
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| BayCare Health | Recruiting | Clearwater | Florida | 33756 | United States |
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| Ascension St. Vincent's | Recruiting | Jacksonville | Florida | 32204 | United States |
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| Miami Cancer Institute, Baptist Health South Florida | Recruiting | Miami | Florida | 33176 | United States |
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| Advent Health Orlando | Recruiting | Orlando | Florida | 32803 | United States |
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| Orlando Health | Recruiting | Orlando | Florida | 32806 | United States |
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| Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
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| Cleveland Clinic Florida- Weston | Recruiting | Weston | Florida | 33331 | United States |
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| Piedmont Healthcare | Recruiting | Atlanta | Georgia | 30309 | United States |
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| Winship Cancer Institute of Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| St. Alphonsus Regional Medical Center | Recruiting | Boise | Idaho | 83704 | United States |
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| Goodman Campbell Brain and Spine | Recruiting | Carmel | Indiana | 46032 | United States |
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| Indiana University, IU Health Methodist Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| KUMC Dept of Neurosurgery | Recruiting | Kansas City | Kansas | 66160 | United States |
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| Univeristy of Louisville Health | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Norton Cancer Institute | Recruiting | Louisville | Kentucky | 40241 | United States |
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| Willis-Knighton Medical Center | Withdrawn | Shreveport | Louisiana | 71103 | United States |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202 | United States |
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| Abbott Northwestern Hospital | Recruiting | Minneapolis | Minnesota | 55407 | United States |
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| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55414 | United States |
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| University of Nebraska | Recruiting | Omaha | Nebraska | 68198 | United States |
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| Clinical Research dep. Davison Place. Englewood Health | Not yet recruiting | Englewood | New Jersey | 07631 | United States |
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| Albany Medical Center | Recruiting | Albany | New York | 12208 | United States |
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| Mount Sinai Hospital | Active, not recruiting | New York | New York | 10029 | United States |
| SUNY Upstate Medical Center | Recruiting | Syracuse | New York | 13210 | United States |
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| Montefiore Einstein | Recruiting | The Bronx | New York | 10467 | United States |
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| Westchester Medical Center | Recruiting | Valhalla | New York | 10595 | United States |
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| University of North Carolina Health | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| Vidant Heath - ECU Medical Center | Recruiting | Greenville | North Carolina | 27834 | United States |
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| Atlantic Brain & Spine | Recruiting | Wilmington | North Carolina | 28401 | United States |
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| Mayfield Brain and Spine | Recruiting | Cincinnati | Ohio | 45209 | United States |
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| Kettering Health | Recruiting | Kettering | Ohio | 45429 | United States |
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| St Luke's University Health, Sacred Heart Campus | Recruiting | Allentown | Pennsylvania | 18102 | United States |
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| Penn State Health | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Allegheny Health Network | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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| Brown University Health | Recruiting | Providence | Rhode Island | 02906 | United States |
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| CHI Memorial Hospital, CommonSpirit | Recruiting | Chattanooga | Tennessee | 37404 | United States |
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| UT Southwestern Simmons Cancer Center | Recruiting | Dallas | Texas | 75235 | United States |
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| Baylor St. Luke's Medical Center | Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| University of Texas Health Science Center of San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| Texas Oncology-The Woodlands | Recruiting | The Woodlands | Texas | 77380 | United States |
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| INOVA Health | Recruiting | Fairfax | Virginia | 22031 | United States |
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| Virginia Mason | Recruiting | Seattle | Washington | 98101 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
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