Clinical trial NCT02914067: Cognitive Biomarkers in Pediatric Brain Tumor Patients
Official title: Cognitive Biomarkers in Pediatric Brain Tumor Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Brain Tumor
Keywords: Pediatric brain tumors
Cognitive deficits
Resting state functional connectivity
NIH toolbox
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Children's Discovery Institute
name: Neurosurgery Research & Education Foundation
name: The Andrew McDonough B+ Foundation
First posted: 2016-09-26
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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: 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)
* 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 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)

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, along with 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, along with 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

Primary outcomes:
measure: Identify reliable peri-diagnostic estimators of cognition as measured by neurocognitive testing
timeFrame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
measure: Identify reliable peri-diagnostic estimators of cognition as measured by advanced resting-state functional connectivity MRI (rsfcMRI) data
timeFrame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
measure: 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)
timeFrame: Up to 27 months
measure: Identify reliable peri-diagnostic estimators of brain function as measured by neurocognitive testing
timeFrame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
measure: Identify reliable peri-diagnostic estimators of brain function as measured by advanced resting-state functional connectivity MRI (rsfcMRI) data
timeFrame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Stephanie Perkins, M.D.
role: PRINCIPAL_INVESTIGATOR
References: