TRLS-05 - Erin Dunbar.mp4
A multicenter observational study of Cs-131 seeds embedded in a collagen carrier tile for newly diagnosed and recurrent operable intracranial neoplasms –Trial in progress
Contact Presenter
Erin Dunbar1, D. Jay McCracken1, Adam Nowlan1, Clark Chen2, Kathryn Dusenbery2, Clara Ferreira2, Rupesh Kotecha3, Michael McDermott3, Sivakumar Jaikumar4, Colette Shen4, David Monyak5, John Trusheim5, John Wanebo6, Samuel Day7, Stuart Lee8, Zabi Wardak9, Toral Patel9, Mehee Choi10, Lisa Misell10, David Brachman10
1Piedmont Atlanta Hospital Piedmont Healthcare, Atlanta, Georgia, USA. 2University of Minnesota, Minneapolis, Minnesota, USA. 3Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA. 4University of North Carolina Chapel Hill, Chapel Hill, North Carolina, USA. 5Virginia Piper Cancer Institute, part of Allina Health, Minneapolis, Minnesota, USA. 6HonorHealth Research Institute, Scottsdale, Arizona, USA. 7Arizona Center for Cancer Care, Scottsdale, Arizona, USA. 8Vidant Health, Greenville, North Carolina, USA. 9UT Southwestern Medical Center, Dallas, Texas, USA. 10GT Medical Technologies, Inc, Tempe, Arizona, USA
Background: For patients with operable intracranial neoplasms, there are opportunities to augment local control beyond traditional methods, such as external beam radiation therapy (EBRT),. Brachytherapy, the implantation of radioactive sources into the resection cavity, can be useful in this setting by providing immediate initiation of radiation and limiting the exposure of surrounding normal tissue to radiation. Traditional intracranial brachytherapy methods have been limited by uneven dose distributions, complicated workflows, extended procedural times, the cost of dedicated equipment, and frequent adverse events. To address these issues, a permanently implanted device with Cs-131 radiation seeds embedded in a bioresorbable collagen carrier tile (GammaTile, GT Medical Technologies, Tempe, AZ USA) was developed. Described as surgically targeted radiation therapy (STaRT), it is FDA-cleared for use in newly-diagnosed malignant intracranial neoplasms and recurrent intracranial tumors, including brain metastases, and has demonstrated excellent safety and local control in early commercial use. The primary objectives of this multicenter, prospective, observational (phase IV) registry study [NCT04427384] are to evaluate “real-world” clinical outcomes and patient-reported outcomes that measure the safety and efficacy of STaRT using the device.
Methods: Subjects (N=600) at up to 50 enrolling sites undergoing resection of brain tumors of any pathology with intra-operative GammaTile placement are eligible for enrollment. We project 40% of enrollees to have brain metastasis. Tumor pathology, overall survival, radiation- and surgery-related adverse events, quality of life, serial MRIs, and timing of surgical bed recurrence and/or distant recurrence will be collected. The powered primary endpoint for recurrent brain metastases, surgical bed-progression free survival, will compare STaRT to standard-of-care benchmarks. This study will be the first observational study of resection plus GammaTile. Results will be used to benchmark clinical outcomes in the real-world setting, allow for comparisons to existing treatments, and facilitate the design of future clinical trials.
Contact Presenter
Erin Dunbar1, D. Jay McCracken1, Adam Nowlan1, Clark Chen2, Kathryn Dusenbery2, Clara Ferreira2, Rupesh Kotecha3, Michael McDermott3, Sivakumar Jaikumar4, Colette Shen4, David Monyak5, John Trusheim5, John Wanebo6, Samuel Day7, Stuart Lee8, Zabi Wardak9, Toral Patel9, Mehee Choi10, Lisa Misell10, David Brachman10
1Piedmont Atlanta Hospital Piedmont Healthcare, Atlanta, Georgia, USA. 2University of Minnesota, Minneapolis, Minnesota, USA. 3Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA. 4University of North Carolina Chapel Hill, Chapel Hill, North Carolina, USA. 5Virginia Piper Cancer Institute, part of Allina Health, Minneapolis, Minnesota, USA. 6HonorHealth Research Institute, Scottsdale, Arizona, USA. 7Arizona Center for Cancer Care, Scottsdale, Arizona, USA. 8Vidant Health, Greenville, North Carolina, USA. 9UT Southwestern Medical Center, Dallas, Texas, USA. 10GT Medical Technologies, Inc, Tempe, Arizona, USA
Background: For patients with operable intracranial neoplasms, there are opportunities to augment local control beyond traditional methods, such as external beam radiation therapy (EBRT),. Brachytherapy, the implantation of radioactive sources into the resection cavity, can be useful in this setting by providing immediate initiation of radiation and limiting the exposure of surrounding normal tissue to radiation. Traditional intracranial brachytherapy methods have been limited by uneven dose distributions, complicated workflows, extended procedural times, the cost of dedicated equipment, and frequent adverse events. To address these issues, a permanently implanted device with Cs-131 radiation seeds embedded in a bioresorbable collagen carrier tile (GammaTile, GT Medical Technologies, Tempe, AZ USA) was developed. Described as surgically targeted radiation therapy (STaRT), it is FDA-cleared for use in newly-diagnosed malignant intracranial neoplasms and recurrent intracranial tumors, including brain metastases, and has demonstrated excellent safety and local control in early commercial use. The primary objectives of this multicenter, prospective, observational (phase IV) registry study [NCT04427384] are to evaluate “real-world” clinical outcomes and patient-reported outcomes that measure the safety and efficacy of STaRT using the device.
Methods: Subjects (N=600) at up to 50 enrolling sites undergoing resection of brain tumors of any pathology with intra-operative GammaTile placement are eligible for enrollment. We project 40% of enrollees to have brain metastasis. Tumor pathology, overall survival, radiation- and surgery-related adverse events, quality of life, serial MRIs, and timing of surgical bed recurrence and/or distant recurrence will be collected. The powered primary endpoint for recurrent brain metastases, surgical bed-progression free survival, will compare STaRT to standard-of-care benchmarks. This study will be the first observational study of resection plus GammaTile. Results will be used to benchmark clinical outcomes in the real-world setting, allow for comparisons to existing treatments, and facilitate the design of future clinical trials.