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Cognitive Testing + Brain Imaging for Childhood Brain Cancer

N/A

Recruiting

Led By Josh Rubin, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort 1: Between 4 and 18 years of age, inclusive, with newly diagnosed primary brain tumor of any location and any histology, having a life expectancy of at least one year, and able to understand and willing to consent or assent to the research proposed, along with consent of legal guardian(s) if applicable

Be younger than 65 years old

Must not have

Cohort 4: Contraindication to MRI scan (i.e. due to cardiac pacemaker), presence of dental braces or programmable shunt, patient requires sedation for MRI scan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 27 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will focus on three groups of brain tumor patients aged 4-18 to see if cognitive function can be predicted using imaging and cognitive testing.

Who is the study for?

This trial is for children aged 4-18 with new brain tumors, focusing on those with posterior fossa tumors or related syndromes. Participants need a life expectancy of at least one year and must consent along with their guardians.

What is being tested?

The study aims to collect data on cognitive function using neurocognitive tests and resting-state functional MRI (rsfcMRI) in kids during diagnosis and treatment to predict cognitive outcomes.

What are the potential side effects?

There are no direct side effects from the interventions being studied as they involve non-invasive testing methods like brain scans (rsfcMRI) and cognitive assessments rather than medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 4 and 18 years old with a new brain tumor diagnosis and expected to live at least one more year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have an MRI due to a pacemaker, dental braces, or needing sedation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Magnetic Resonance Imaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort 4 Arm BExperimental Treatment2 Interventions

* During standard of care MRI images, rsfcMRI imaging will be performed which will add 15 minutes of scan time. * Will complete cognitive testing using the NIH Toolbox Cognitive Battery * All patients will complete the Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale - 5 questionnaire. All patients will complete a self-reported assessment of neurological quality of life (QOL). Adult patients (age ≥ 18 years) will complete the adult version of the Quality of Life in Neurological Disorders (Neuro-QOL) Cognitive Function measure. All pediatric patients will complete the pediatric version of the Neuro-QOL Cognitive Function measure. For patients \<18 years of age and for adult patients with parent present, parent/caregiver will complete the PROMIS® Parent Proxy for cognition. All adult patients will complete the Colorado Learning Difficulties Questionnaire (CLDQ). This questionnaire will be completed by parent/caregiver for patients \< 18 years of age.

Group II: Cohort 4 Arm AExperimental Treatment2 Interventions

Undergo the following MRI images: RSFC MRI, T2/T1 MRI, and DTI. * Will complete cognitive testing using the NIH Toolbox Cognitive Battery * All patients will complete the Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale - 5 questionnaire. All patients will complete a self-reported assessment of neurological quality of life (QOL). Adult patients (age ≥ 18 years) will complete the adult version of the Quality of Life in Neurological Disorders (Neuro-QOL) Cognitive Function measure. All pediatric patients will complete the pediatric version of the Neuro-QOL Cognitive Function measure. For patients \<18 years of age and for adult patients with parent present, parent/caregiver will complete the PROMIS® Parent Proxy for cognition. All adult patients will complete the Colorado Learning Difficulties Questionnaire (CLDQ). This questionnaire will be completed by parent/caregiver for patients \< 18 years of age.

Group III: Cohort 3Experimental Treatment1 Intervention

* During standard of care MRI images, rsfcMRI imaging will be performed which will add 15 minutes of scan time. * rsfcMRI will be obtained annually for total of 3 rsfcMRIs for each patient.

Group IV: Cohort 2Experimental Treatment2 Interventions

* Patients with diagnosis of a posterior tumor will undergo neurocognitive testing utilizing the NIH Toolbox. Testing will be every 6 months for children currently receiving therapy and annually for those that have completed all therapy for a total of 3 sessions. During standard of care MRI images, rsfcMRI imaging will be performed which will add 15 minutes of time. rsfcMRI will be obtained every 6 months for children currently receiving therapy and annually for those that have completed therapy for a total of 3 rsfcMRIs for each patient. * Patients in Cohort 1 will also be eligible to continue with the longitudinal assessment as just described. These participants will then undergo repeat neurocognitive testing using the NIH toolbox 6-9 months for an additional 3 testing sessions. rsfcMRI will be obtained during their follow-up imaging at 6-9 month intervals for a total of 3 additional rsfcMRIs (4 total scans).

Group V: Cohort 1Experimental Treatment2 Interventions

* Prior to surgery, subjects will have a complete standard of care history and physical exam by the neurosurgeon and then undergo peri-diagnostic neurocognitive testing utilizing the NIH Toolbox Cognitive Battery computer testing software for iPad (will take 45 minutes). The peri-diagnostic period will be defined as the period from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later. * Participants will also undergo a rsfcMRI during their standard of care MRI imaging which will add 15 minutes to their scan time

0 / 2Eligibility criteria met