Status:
UNKNOWN
Glioma Supra Marginal Incision Trial
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Sunnybrook Research Institute
Conditions:
High Grade Glioma
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
G-SUMIT is a pilot, phase II,randomized controlled trial to evaluate the feasibility of performing a large-scale trial in patients undergoing surgery for first-time diagnosis of high grade glioma (HGG...
Detailed Description
This pilot, multi-centre, pragmatic randomized controlled trial is planned to simulate all aspects of a larger definitive trial comparing conventional versus supramarginal tumor resection at the time ...
Eligibility Criteria
Inclusion
- Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG;
- Age ≥18 ≤ 85 years;
- Karnofsky Performance Score ≥ 60;
- Location of tumor in a safe anatomical location and
- Patient or substitute decision maker (SDM) able to understand and consent to study participation.
Exclusion
- Multi-focal tumor, gliomatosis cerebri (≥3 lobes of the brain affected), tumors crossing the midline, or leptomeningeal enhancement;
- Previous craniotomy for tumor excision (stereotactic biopsy is permitted);
- Known metastatic cancer;
- Uncorrectable coagulopathy;
- Unable to obtain GAD-enhanced brain MRI.
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04737577
Start Date
February 5 2021
End Date
February 1 2025
Last Update
June 18 2023
Active Locations (6)
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1
The Pennsylvania State University
University Park, Pennsylvania, United States, 16802
2
Mackenzie Health Sciences Center
Edmonton, Alberta, Canada, T6G 2B7
3
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
4
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8