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 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT02500459
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of supratentorial WHO Grade III or IV Glioma (High Grade Glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and surgical resection of the enhancing tumor is clinically indicated.
* Karnofsky Performance Status 70-100;
* MRI demonstration of an enhancing mass of more than 1 cm\^3 and less than 100 cm\^3;
* Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent; and
* Laboratory values within the following ranges:
* Absolute neutrophil count (ANC) ≥ 1,500 / μL;
* Platelet count ≥ 100,000 / μL;
* Hemoglobin ≥ 10 g / dL;
* Estimated glomerular filtration rate (eGFR) of at least 50 mL/min
Exclusion Criteria:
* Patient is mentally or legally incapacitated at the time of the study;
* Known HIV(+) or has been diagnosed with AIDS;
* Participation in another investigational drug study in the prior 4 weeks;
* Positive pregnancy test in a female;
* Patient, in the opinion of the investigator, is likely to be poorly compliant.
* Diffuse subependymal or CSF disease;
* Tumors involving the cerebellum
* Active infection requiring treatment;
* Unexplained febrile illness;
* Radiation or chemotherapy within 4 weeks of enrollment
* Systemic diseases associated with unacceptable anesthesia or operative risk;
* Personal or family history of bleeding diathesis and a coagulation profile that would preclude patient from undergoing a neurosurgical procedure
* Subject must take anticoagulants, or antiplatelet agents, including NSAIDs that cannot be stopped for surgery
* Inability to undergo magnetic resonance imaging.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02500459
Study Brief:
Protocol Section:
NCT02500459