Cognitive Biomarkers in Pediatric Brain Tumor Patients

Phase

N/A

Condition

Brain Tumor (Pediatric)

Treatment

Neurocognitive testing

rsfcMRI

Clinical Study ID

NCT02914067

201609023

Ages 4-18
All Genders

Study Summary

The investigators will focus on three cohorts of brain tumor patients aged, 4-18 years, to answer two critical questions: 1) Can the investigators acquire high quality data relevant to cognitive function during the peri-diagnostic period and, 2) can the investigators develop predictive models for cognitive outcomes using serial examination of functional imaging and cognitive function. Any patient with a newly diagnosed brain tumor aged 4-18 will be eligible for enrollment in cohort 1. Only patients with previously diagnosed tumors of the posterior fossa will be eligible for cohort 2. For cohort 3, eligible patients will include patients with a clinical diagnosis of posterior fossa syndrome with physical impairments that prohibit completion of the NIH Toolbox Cognitive Battery. The investigators have decided to expand the eligible tumor types to better capture the most significant deficit variability that can be caused by tumors outside the posterior fossa. Thus, this focus will provide a platform to analyze the impact that different tumor types and different standard treatments have on cognitive dysfunction. The rationale for inclusion of subjects on cohort 3 is that posterior fossa syndrome is one of the most cognitively devastating diagnoses following a posterior fossa surgery. The causes of posterior fossa syndrome and unknown and there are currently no interventions to improve symptoms. RsfcMRI would offer a novel and non-invasive assessment of posterior fossa syndrome patients by assessing connectivity within and outside of the cerebellum. Expanding the tumor eligibility will allow us to further explore the effect tumor location will have on cognitive testing and rsfcMRI. Here, repeated evaluations on and off therapy will provide the necessary data points to establish trajectories of cognitive development and recovery in this population.

Eligibility Criteria

Inclusion

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, alongwith consent of legal guardian(s) if applicable

Exclusion

Exclusion Criteria:

Presence of visual impairment to an extent that the patient is unable to completethe 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 eitherundergoing active treatment for posterior fossa tumor or who have completedtreatment 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, alongwith consent of legal guardian(s) if applicable

Exclusion Criteria:

Presence of visual impairment to an extent that the patient is unable to completethe 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, alongwith 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, alongwith 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

Study Design