Actively Recruiting

Phase Not Applicable
Age: 4Years - 18Years
All Genders
NCT02914067

Cognitive Biomarkers in Pediatric Brain Tumor Patients

Led by Washington University School of Medicine · Updated on 2025-11-21

200

Participants Needed

1

Research Sites

640 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

C

Children's Discovery Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cognitive Biomarkers in Pediatric Brain Tumor Patients

Who Can Participate

Age: 4Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 4 and 18 years of age, inclusive
  • Newly diagnosed primary brain tumor of any location and any histology (Cohort 1)
  • Life expectancy of at least one year
  • Able to understand and willing to consent or assent to the research, with guardian consent if applicable
  • Previous diagnosis of a posterior fossa brain tumor, undergoing or completed treatment (Cohort 2)
  • Clinical diagnosis of post-operative posterior fossa syndrome and inability to complete NIH Toolbox cognitive testing (Cohort 3)
  • Between 12 and 30 years of age, inclusive
  • Diagnosis of a brain tumor more than 3 years prior to enrollment
  • Able to complete a 1-hour MRI scan without sedation (Cohort 4)
Not Eligible

You will not qualify if you...

  • Visual impairment preventing completion of computer testing (Cohorts 1 and 2)
  • Contraindication to MRI scan such as presence of cardiac pacemaker (All cohorts)
  • Programmable shunt (Cohort 1)
  • Presence of dental braces or programmable shunt (Cohort 4)
  • Patient requires sedation for MRI scan (Cohort 4)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

S

Stephanie Perkins, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

5

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