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:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT02914067
Eligibility Criteria:
Cohort 1 (30 patients will be enrolled to this cohort)
Inclusion Criteria:
* Between 4 and 18 years of age, inclusive
* Newly diagnosed primary brain tumor of any location and any histology
* Life expectancy of at least one year
* Able to understand and willing to consent or assent to the research proposed, along with consent of legal guardian(s) if applicable
Exclusion Criteria:
* Presence of visual impairment to an extent that the patient is unable to complete the computer testing
* Contraindication to MRI scan (i.e. due to cardiac pacemaker)
* Programmable Shunt
Cohort 2 (150 patients will enrolled to this cohort. This may include some or all of the patients enrolled to Cohort 1.)
Inclusion Criteria:
* Between 4 and 18 years of age, inclusive
* Previous diagnosis of a posterior fossa brain tumor; patients who are either undergoing active treatment for posterior fossa tumor or who have completed treatment will be eligible for study enrollment
* Life expectancy of at least one year
* Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable
Exclusion Criteria:
* Presence of visual impairment to an extent that the patient is unable to complete the computer testing
* Contraindication to MRI scan (i.e. due to cardiac pacemaker)
Cohort 3 (20 patients will be enrolled to this cohort. This may include some or all of the patients enrolled to Cohort 1) Inclusion Criteria
* Between 4 and 18 years of age, inclusive
* Previous diagnosis of a posterior fossa brain tumor
* Clinical diagnosis of post-operative posterior fossa syndrome
* Inability to complete NIH Toolbox
* Life expectancy of at least one year
* Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable
Exclusion Criteria
* Contraindication to MRI scan (i.e. due to cardiac pacemaker)
Cohort 4 (50 Patients will be enrolled to Cohort 4. This will include patients previously enrolled on Cohorts 1-3 above.)
Inclusion Criteria
* Between 12-30 years of age, inclusive
* Diagnosis of a brain tumor \>3 years prior to study enrollment
* Life expectancy of at least one year
* Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable
* Patient must be able to complete a 1 hour MRI scan without sedation
Exclusion Criteria
* Contraindiciation to MRI scan (i.e. due to cardian pacemaker)
* Presence of dental braces or programmable shunt
* Patient requires sedation for MRI scan
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT02914067
Study Brief:
Protocol Section:
NCT02914067