Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
M
Mitesh Shah, MD
Primary Investigator
Enrolling By Invitation
100 years and younger
All
Phase
N/A
600 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
The objectives of this registry study are to evaluate real-world clinical outcomes andd outcomes that measure the effectiveness and safety of STaRT.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- Patients 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Brain Tumor, Glioblastoma, Meningioma
-
Age: - 100 Years
-
Gender: All
Inclusion Criteria:
- Patients who undergo maximum safe resection of intracranial neoplasm(s) ANDGammaTiles.
- Willing and able to provide informed consent and to participate in all evaluations.
Exclusion Criteria:
- Inability to undergo pre-operative and post-operative imaging for disease and implant.
- Major medical or psychiatric illness, which, in the investigator's opinion wouldvent completion of treatment, ability to complete assessments at the time ofd/or interfere with follow ups.
- Lack of English language fluency sufficient to allow for completion of neurocognitived QOL tests (which are in English).
Updated on
01 Aug 2024.
Study ID: GTM-101, SNEU-GTMEDICAL-START, 11857
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