Cognitive Biomarkers in Pediatric Brain Tumor Patients



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:4 - 18
Updated:3/16/2019
Start Date:October 26, 2016
End Date:January 30, 2022
Contact:Josh Rubin, M.D., Ph.D.
Email:rubin_j@wustl.edu
Phone:314-286-2790

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The investigators will focus on two 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. The rationale for of the focus on these patients is that
first, the posterior fossa is the most common location for pediatric brain tumors and
therefore this focus will impact the largest segment of this patient population. Second,
three tumors commonly occur here, medulloblastoma, ependymoma and pilocytic astrocytoma.
These are treated with surgery, radiation and chemotherapy (medulloblastoma), surgery and
radiation therapy (ependymoma) or surgery only (pilocytic astrocytoma). Thus, this focus will
provide a platform to analyze the impact that different tumor types and different standard
treatments have on cognitive dysfunction. Finally, the fact that all subjects will have
tumors of the same brain region will control for the effect that 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.


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)

Cohort 2 (30 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)
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Josh Rubin, M.D., Ph.D.
Phone: 314-286-2790
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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