[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04427384":3,"trial-entities:NCT04427384":691,"trial-summary:NCT04427384":697},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":50,"sex":51,"minimum_age":27,"maximum_age":27,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":56,"locations":60,"central_contacts":676,"overall_officials":685,"references":689,"see_also_links":690},"NCT04427384","GTM-101","Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)","A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms","RECRUITING","2028-12-31","2026-07","2026-07-22","2020-09-11","GT Medical Technologies, Inc.","INDUSTRY",false,"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.",[19,20,21,22,23,24],"Brain Tumor, Recurrent","Brain Tumor","Brain Tumor, Primary","Brain Tumor - Metastatic","Brain Tumor, Adult: Glioblastoma","Brain Tumor, Adult Meningioma",[],"OBSERVATIONAL",null,[],{"count":30,"type":31},600,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","GammaTile","Surgically Targeted Radiation Therapy",[35],[39,43,46],{"measure":40,"description":41,"timeFrame":42},"Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects","No contrast enhancement in the area of the surgical bed","12 months",{"measure":44,"description":41,"timeFrame":45},"Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects","3 years",{"measure":47,"description":48,"timeFrame":49},"Overall Survival in High Grade Glioma Subjects","Median duration of survival of subjects following surgical resection of tumor","9 months",[],"ALL",{"inclusion":53,"exclusion":54,"raw_text":55},[],[],"Inclusion Criteria:\n\n1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.\n2. Willing and able to provide informed consent and to participate in all evaluations.\n\nExclusion Criteria:\n\n1. Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.\n2. Major medical or psychiatric illness, which, in the investigator's opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and\u002For interfere with follow ups.\n3. Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.",[57,58,59],"CHILD","ADULT","OLDER_ADULT",[61,76,88,101,112,125,137,149,161,172,183,196,206,218,225,237,249,260,267,278,293,303,314,327,336,345,358,364,375,386,394,406,418,432,439,451,464,474,482,493,506,518,530,542,554,568,583,597,608,619,625,635,648,661],{"facility":62,"status":8,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":73},"HonorHeath Scottsdale Osborn Medical Center","Phoenix","Arizona","85027","United States",[68,71],{"name":69,"role":70},"John Wanebo, MD","CONTACT",{"name":69,"role":72},"PRINCIPAL_INVESTIGATOR",{"lat":74,"lon":75},33.44838,-112.07404,{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":66,"contacts":81,"geoPoint":85},"University of Arkansas Medical Center","Little Rock","Arkansas","72205",[82],{"name":83,"role":70,"phone":84},"Analiz Rodriguez, MD, 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System","Detroit","Michigan","48202",[370],{"name":371,"role":70},"Adam M Robin, MD",{"lat":373,"lon":374},42.33143,-83.04575,{"facility":376,"status":8,"city":377,"state":378,"zip":379,"country":66,"contacts":380,"geoPoint":383},"Abbott Northwestern Hospital","Minneapolis","Minnesota","55407",[381],{"name":382,"role":70},"John Trusheim, MD",{"lat":384,"lon":385},44.97997,-93.26384,{"facility":387,"status":8,"city":377,"state":378,"zip":388,"country":66,"contacts":389,"geoPoint":393},"University of Minnesota","55414",[390,392],{"name":391,"role":70},"Lindsey Sloan, MD, PhD",{"name":391,"role":72},{"lat":384,"lon":385},{"facility":395,"status":8,"city":396,"state":397,"zip":398,"country":66,"contacts":399,"geoPoint":403},"University of Nebraska","Omaha","Nebraska","68198",[400],{"name":401,"role":70,"phone":402},"Michele Aizenberg, 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Englewood Health","New Jersey","07631",[411,413],{"name":412,"role":70},"Kevin Yao, MD",{"name":414,"role":70},"Dubin David, MD",{"lat":416,"lon":417},40.89288,-73.97264,{"facility":419,"status":8,"city":420,"state":421,"zip":422,"country":66,"contacts":423,"geoPoint":429},"Albany Medical Center","Albany","New York","12208",[424,427],{"name":425,"role":70,"phone":426},"Tuba Ahmed","518-262-5088",{"name":428,"role":72},"Alexandra Paul, MD",{"lat":430,"lon":431},42.65258,-73.75623,{"facility":433,"status":434,"city":421,"state":421,"zip":435,"country":66,"geoPoint":436},"Mount Sinai Hospital","ACTIVE_NOT_RECRUITING","10029",{"lat":437,"lon":438},40.71427,-74.00597,{"facility":440,"status":8,"city":441,"state":421,"zip":442,"country":66,"contacts":443,"geoPoint":448},"SUNY Upstate Medical Center","Syracuse","13210",[444,447],{"name":445,"role":70,"phone":446},"Harish Babu, MD","315-464-4470",{"name":445,"role":72},{"lat":449,"lon":450},43.04812,-76.14742,{"facility":452,"status":8,"city":453,"state":421,"zip":454,"country":66,"contacts":455,"geoPoint":461},"Montefiore Einstein","The Bronx","10467",[456,459],{"name":457,"role":70,"phone":458},"Genesis Liriano","718-920-4321",{"name":460,"role":72},"Vijay Agarwal, MD",{"lat":462,"lon":463},40.84985,-73.86641,{"facility":465,"status":8,"city":466,"state":421,"zip":467,"country":66,"contacts":468,"geoPoint":471},"Westchester Medical Center","Valhalla","10595",[469],{"name":470,"role":70},"Simon Hanft",{"lat":472,"lon":473},41.07482,-73.77513,{"facility":475,"status":434,"city":476,"state":477,"zip":478,"country":66,"geoPoint":479},"University of North Carolina Health","Chapel Hill","North Carolina","27599",{"lat":480,"lon":481},35.9132,-79.05584,{"facility":483,"status":8,"city":484,"state":477,"zip":485,"country":66,"contacts":486,"geoPoint":490},"Vidant Heath - ECU Medical Center","Greenville","27834",[487],{"name":488,"role":70,"phone":489},"Stuart Lee, MD","252-847-1550",{"lat":491,"lon":492},35.61266,-77.36635,{"facility":494,"status":8,"city":495,"state":477,"zip":496,"country":66,"contacts":497,"geoPoint":503},"Atlantic Brain & Spine","Wilmington","28401",[498,501],{"name":499,"role":70,"email":500},"Bridgette Smith","b.smith@atlanticbrainandspine.com",{"name":502,"role":72},"Jeffrey Beecher, DO",{"lat":504,"lon":505},34.23556,-77.94604,{"facility":507,"status":8,"city":508,"state":509,"zip":510,"country":66,"contacts":511,"geoPoint":515},"Mayfield Brain and Spine","Cincinnati","Ohio","45209",[512],{"name":513,"role":70,"phone":514},"Vincent DiNapoli, MD","513-888-7564",{"lat":516,"lon":517},39.12711,-84.51439,{"facility":519,"status":8,"city":520,"state":509,"zip":521,"country":66,"contacts":522,"geoPoint":527},"Kettering Health","Kettering","45429",[523,526],{"name":524,"role":70,"phone":525},"Mark Hoeprich, MD","937-298-4331",{"name":524,"role":72},{"lat":528,"lon":529},39.6895,-84.16883,{"facility":531,"status":8,"city":532,"state":533,"zip":534,"country":66,"contacts":535,"geoPoint":539},"St Luke's University Health, Sacred Heart Campus","Allentown","Pennsylvania","18102",[536,538],{"name":537,"role":70},"William Smith, MD",{"name":537,"role":72},{"lat":540,"lon":541},40.60843,-75.49018,{"facility":543,"status":8,"city":544,"state":533,"zip":545,"country":66,"contacts":546,"geoPoint":551},"Penn State Health","Hershey","17033",[547,549],{"name":548,"role":70},"Rachel Horstman",{"name":550,"role":72},"Sean Mahase, MD",{"lat":552,"lon":553},40.28592,-76.65025,{"facility":555,"status":8,"city":556,"state":533,"zip":557,"country":66,"contacts":558,"geoPoint":565},"Allegheny Health Network","Pittsburgh","15212",[559,563],{"name":560,"role":70,"phone":561,"email":562},"Sarah Kimutis","412-359-3565","sarah.kimutis@ahn.org",{"name":564,"role":72},"Matthew Shepard, MD",{"lat":566,"lon":567},40.44062,-79.99589,{"facility":569,"status":8,"city":570,"state":571,"zip":572,"country":66,"contacts":573,"geoPoint":580},"Brown University Health","Providence","Rhode Island","02906",[574,578],{"name":575,"role":70,"phone":576,"email":577},"Clarck Chen, MD, PhD","401-793-9166","clark.chen@lifespan.org",{"name":579,"role":72},"Clark Chen, MD, PhD",{"lat":581,"lon":582},41.82399,-71.41283,{"facility":584,"status":8,"city":585,"state":586,"zip":587,"country":66,"contacts":588,"geoPoint":594},"CHI Memorial Hospital, CommonSpirit","Chattanooga","Tennessee","37404",[589,592],{"name":590,"role":70,"email":591},"Ginger Whisman","ginger.whisman@commonspirit.org",{"name":593,"role":72},"Ranjith Babu, MD",{"lat":595,"lon":596},35.04563,-85.30968,{"facility":598,"status":8,"city":599,"state":600,"zip":601,"country":66,"contacts":602,"geoPoint":605},"UT Southwestern Simmons Cancer Center","Dallas","Texas","75235",[603],{"name":604,"role":70},"Toral Patel, MD",{"lat":606,"lon":607},32.78306,-96.80667,{"facility":609,"status":8,"city":610,"state":600,"zip":611,"country":66,"contacts":612,"geoPoint":616},"Baylor St. Luke's Medical Center | Baylor College of Medicine","Houston","77030",[613],{"name":614,"role":70,"phone":615},"Akash Patel, MD","713-798-8810",{"lat":617,"lon":618},29.76328,-95.36327,{"facility":620,"status":8,"city":610,"state":600,"zip":611,"country":66,"contacts":621,"geoPoint":624},"Houston Methodist Hospital",[622],{"name":623,"role":70},"David Baskin, MD",{"lat":617,"lon":618},{"facility":626,"status":8,"city":627,"state":600,"zip":628,"country":66,"contacts":629,"geoPoint":632},"University of Texas Health Science Center of San Antonio","San Antonio","78229",[630],{"name":631,"role":70},"John Floyd, MD",{"lat":633,"lon":634},29.42412,-98.49363,{"facility":636,"status":8,"city":637,"state":600,"zip":638,"country":66,"contacts":639,"geoPoint":645},"Texas Oncology-The Woodlands","The Woodlands","77380",[640,643],{"name":641,"role":70,"email":642},"James Zhu, M.D., Ph.D.","james.zhu@usoncology.com",{"name":644,"role":72},"James Zhu, M.D., Ph.D",{"lat":646,"lon":647},30.15799,-95.48938,{"facility":649,"status":8,"city":650,"state":651,"zip":652,"country":66,"contacts":653,"geoPoint":658},"INOVA Health","Fairfax","Virginia","22031",[654,657],{"name":655,"role":70,"phone":656},"Daniel Kim, MD","571-472-0606",{"name":655,"role":72},{"lat":659,"lon":660},38.84622,-77.30637,{"facility":662,"status":8,"city":663,"state":664,"zip":665,"country":66,"contacts":666,"geoPoint":673},"Virginia Mason","Seattle","Washington","98101",[667,670,671],{"name":668,"role":70,"phone":669},"Huong Pham, MD","206-287-6278",{"name":668,"role":72},{"name":672,"role":72},"Roby Ryan, MD",{"lat":674,"lon":675},47.60621,-122.33207,[677,681],{"name":678,"role":70,"phone":679,"email":680},"Michael A. Garcia, MD, MS","(833) 662-0044","mgarcia@gtmedtech.com",{"name":682,"role":70,"phone":683,"email":684},"Sita Patel, PhD, PharmD","(833)662-0044","spatel@gtmedtech.com",[686],{"name":678,"affiliation":687,"role":688},"GT Medical Technologies","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":692,"biomarkers":696},[693,694,695],"Brain Neoplasm","Glioblastoma","Meningioma",[],{"nct_id":4,"found":698,"summary":699,"prompt_version":709},true,{"design":700,"status":701,"heading":702,"summary":703,"follow_up":704,"word_count":705,"commitments":706,"compensation":707,"drugs_mentioned":708},"This is an observational study, meaning researchers will collect data from patients who have already received GammaTile treatment. It aims to include 600 participants.","completed","Registry of Patients With Brain Tumors Treated With GammaTiles","This study is a registry, meaning it collects information from patients who have already received a treatment called GammaTile (Surgically Targeted Radiation Therapy) for various brain tumors. The goal is to understand how well GammaTile works in a real-world setting and its safety. You may be able to join if you have a brain tumor that has been surgically removed and you have received GammaTile treatment. The study will look at how long patients live, how long they remain free from tumor recurrence around the surgery site, and their quality of life. This study plans to include about 600 participants.","Participants will be followed for up to 5 years after treatment.",100,"Data will be collected at 1, 3, 6, 9, 12, 18, and 24 months, then every 6 months through 5 years. This includes information on local control, overall survival, quality of life, and side effects.","Not stated in the trial record.",[35],"v2"]