Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT02085304
Eligibility Criteria:
Inclusion Criteria:
* single enhancing lesion of the brain with MRI appearance consistent with GBM
* Must be appropriate for Gliadel® wafer implant
* Pathologic confirmation of GBM
* no gross residual tumor found on the immediate postoperative MRI scan
* Volumetric measurements of the resection cavity margin being \< 50 cc
* Karnofsky performance status (KPS) 80% or better
* Must be able to undergo MRI imaging with gadolinium
* Willingness to have follow up visits at Barrow Neurological Institute(BNI)
Exclusion Criteria:
* multi-focal tumors
* tumors which extend across the corpus callosum,
* residual nodular disease
* Tumors, with a contraindication to Gliadel® implant, such as an anticipated extensive ventricular opening resulting from complete resection.
* Tumor measuring greater than 50cc in volume (on post-operative scan) Volume \< 50 cc if volume if a significant volume of eloquent tissue is included in the proposed treatment volume
* Unable to undergo MRI with gadolinium
* History of cancer within 2 years of GBM diagnosis (basal and squamous cell skin cancers are allowed)
* Patient is not willing to follow up at BNI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02085304
Study Brief:
Protocol Section:
NCT02085304