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NCT02914067 | RECRUITING | Childhood Brain Tumor

Cognitive Biomarkers in Pediatric Brain Tumor Patients
Sponsor:

Washington University School of Medicine

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.

Condition or disease

Childhood Brain Tumor

Intervention/treatment

Neurocognitive testing

rsfcMRI

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Cognitive Biomarkers in Pediatric Brain Tumor Patients
Actual Study Start Date : 2016-10-26
Estimated Primary Completion Date : 2025-11-30
Estimated Study Completion Date : 2028-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 4 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • Cognitive Biomarkers in Pediatric Brain Tumor Patients

    Location Details

    NCT02914067

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    Locations

    RECRUITING

    United States, Missouri

    Washington University School of Medicine

    Saint Louis, Missouri, United States, 63110