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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Neurocognitive testing

    Other intervention
  • rsfcMRI

    Device

    The imaging protocols will be a combined version of a standard of care (SOC) protocol with a research portion. The SOC portion of the pre-surgical scans includes a 3D T2-weighted (T2w) scans and 3D pre- and post-contrast T1-weighted (T1w) images, both at high resolution (1.0 mm3) for use in the intraoperative navigation system. This scan also includes a DTI portion for definition of fiber bundles of interest. The SOC portion of the post-surgical scans includes transverse FLAIR and post-contrast T1w images in all 3 planes. The research portion of the scan will be identical at all 3 time points and include 15 min of rsfcMRI during which the non-sedated subjects will be asked to stay still and awake while looking at a fixation cross

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: Cohort 1Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 2 interventions
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4 Arm AExperimental treatment 2 interventions
Group E: Cohort 4 Arm BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Identify reliable peri-diagnostic estimators of cognition as measured by neurocognitive testing

Time frame
Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
2

Identify reliable peri-diagnostic estimators of cognition as measured by advanced resting-state functional connectivity MRI (rsfcMRI) data

Time frame
Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
3

Predictors of cognitive recovery in children as determined by multiplexed analyses of a combination of potential biomarkers across multiple modalities (rsfcMRI, structural MRI, NIH Toolbox, patient demographics, treatment information)

As dictated by information theory, properly combining predictors across modalities must increase the accuracy of the prediction algorithm, unless a given modality contains no information about the question of interest (in this case, long-term cognitive outcomes).

Time frame
Up to 27 months
4

Identify reliable peri-diagnostic estimators of brain function as measured by neurocognitive testing

Time frame
Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Children's Discovery Institute

Collaborator

Neurosurgery Research & Education Foundation

Collaborator

The Andrew McDonough B+ Foundation

Collaborator