Cognitive Biomarkers in Pediatric Brain Tumor Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorWashington University School of Medicine

About this trial

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

Qualifiers

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

Disqualifiers

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

Between 4 and 18 years of age, inclusive

Trial design

Treatments tested in this trial

  • Neurocognitive testing
  • rsfcMRI

Treatment groups

200 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Washington University School of Medicine

Lead sponsor

Children's Discovery Institute

Collaborator

Neurosurgery Research & Education Foundation

Collaborator

The Andrew McDonough B+ Foundation

Collaborator