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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT02388659
Eligibility Criteria:
Inclusion Criteria:
Patients with brain tumors (55 subjects):
* Age \> 18 years
* Males and females
* All races and ethnicity
* Patients must meet at least one of the 3 following criteria regarding brain tumor diagnosis:
* Histological diagnosis of a brain tumor
* Pre-operative brain MR imaging suggestive of a brain tumor
* Radiographic diagnosis of brain tumor in an inoperable location (e.g. brainstem)
* Pretreatment evaluation required for eligibility include a medical history, physical examination, and neurological exam within 30 days prior to study entry.
* Patient must be able to provide study-specific consent prior to study entry and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.
Karnofsky performance status \> 70%
Patients with non-tumor neurological disorders (50 subjects):
* Males and females
* All races and ethnicities
* Patients with clinically-proven encephalitis (infections, autoimmune and paraneoplastic), demyelinating lesions, vascular lesions (subacute arterial infarct, venous infarct, and vasculitis), hamartomatous lesions, and malformations of cortical development.
Exclusion Criteria:
* Age under 18\*.
* Cardiac pacemaker.
* Intracranial clips, metal implants, or external clips within 50 cm from the head.
* Metal in eye.
* Pregnancy.
* Claustrophobia.
* Obesity or any other factors that provide difficulty with supine pose in the magnet.
* Patients who are unable to provide informed consent.
* Patients who are pregnant or nursing.
* Patients with severe kidney dysfunction or uncontrolled cardiac dysfunction.
* Patients who are claustrophobic or have other contraindication to MRI, such as implanted pacemaker device, vascular cips, surgical slips, prosthetic valves, pacemakers, otologic implants.
* Patients with uncontrolled psychiatric manifestations of their brain tumor.
* Children (age \< 18) are excluded from the study plan because the incidence of astrocytomas and glioblastoma in children is far less than in adults. Although children frequently develop brain tumors, the glial tumors are most often pilocytic astrocytomas. In addition, enrollment of adults will be beneficial for the MRS sequence validation tests in healthy subjects since adults can remain motionless during the MR scans compared to children, giving minimal motion artifacts om the MR data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02388659
Study Brief:
Protocol Section:
NCT02388659