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Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)

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ClinicalTrials.gov Identifier: NCT04427384
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
GT Medical Technologies, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Brain Tumor, Recurrent Brain Tumor Brain Tumor, Primary Brain Tumor - Metastatic Brain Tumor, Adult: Glioblastoma Brain Tumor, Adult Meningioma Device: GammaTile

Detailed Description:
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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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
Actual Study Start Date : September 11, 2020
Estimated Primary Completion Date : October 31, 2028
Estimated Study Completion Date : December 31, 2028


Group/Cohort Intervention/treatment
GammaTile
Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.
Device: GammaTile
Surgically Targeted Radiation Therapy




Primary Outcome Measures :
  1. Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects [ Time Frame: 12 months ]
    No contrast enhancement in the area of the surgical bed

  2. Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects [ Time Frame: 3 years ]
    No contrast enhancement in the area of the surgical bed

  3. Overall Survival in High Grade Glioma Subjects [ Time Frame: 9 months ]
    Median duration of survival of subjects following surgical resection of tumor



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who received STaRT intraoperatively.
Criteria

Inclusion Criteria:

  1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
  2. Willing and able to provide informed consent and to participate in all evaluations.

Exclusion Criteria:

  1. Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
  2. 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/or interfere with follow ups.
  3. Lack of English language fluency sufficient to allow for completion of neurocognitive and QOL tests (which are in English).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427384


Contacts
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Contact: Lisa Misell, PhD GT Medical Technologies (833) 662-0044 lmisell@gtmedtech.com
Contact: Angela Hall GT Medical Technologies ahall@gtmedtech.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Phoenix, Arizona, United States, 85027
Contact: John Wanebo, MD         
United States, Florida
Miami Cancer Institute, Baptist Health South Florida Recruiting
Miami, Florida, United States, 33176
Contact: Rupesh Kotecha, MD         
United States, Georgia
Piedmont Healthcare Recruiting
Atlanta, Georgia, United States, 30309
Contact: Adam Nowlan, MD         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: John Trusheim, MD         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Clark Chen, MD         
United States, North Carolina
University of North Carolina Health Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Colette Shen, MD         
Vidant Recruiting
Greenville, North Carolina, United States, 27834
Contact: Stuart Lee, MD    252-847-1550      
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Toral Patel, MD         
Univertity of Texas Healthy Science Center of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: John Floyd, MD         
Sponsors and Collaborators
GT Medical Technologies, Inc.
Investigators
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Study Director: Lisa Misell, PhD GT Medical Technologies GT Medical Technologies
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Responsible Party: GT Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT04427384    
Other Study ID Numbers: GTM-101
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Glioblastoma
Meningioma
Astrocytoma
Glioma
Brain Diseases
Nervous System Diseases