Understanding the Late Effects of Surviving a Pediatric Brain Tumor

Active, not recruiting

• Conditions: Brain Tumor; Pediatric Cancer; Pediatric Brain Tumor
• Interventions: Diagnostic Test: Diffusion tensor imaging (DTI); Diagnostic Test: Resting state functional connectivity MRI (rs-fcMRI); Behavioral: Wechsler Intelligence Scale for Children - 5th edition (WISC-V); Behavioral: California Verbal Learning Test (CVLT-C); Behavioral: Beery Test of Visual Motor Integration 6th edition; Behavioral: PedsQL Multidimensional Fatigue Scale; Behavioral: Grooved Pegboard; Diagnostic Test: MRI

• Registration Number: NCT03208387
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-28
• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Children Treated for Posterior Fossa Tumors:

• As per medical record or clinical report, successfully completed all medical treatment for either an M0 posterior fossa medulloblastoma without dissemination or posterior fossa low-grade astrocytoma without relapse or evidence of residual disease.
• For medulloblastoma survivors only: Previously treated with gross total resection (GTR), craniospinal irradiation with conformal posterior fossa boost radiotherapy (CSI + Boost) and chemotherapy
• For low grade astrocytoma survivors only: Previously treated with gross total resection ONLY (no chemotherapy or radiotherapy).
• As per medical record or clinician report, between 1-10 years post completion of their medical treatment for their posterior fossa brain tumor.
• Subject is between the ages of 6 through 16 years at time of consent.
• As per medical record or parent report, subject is able to tolerate an MRI without sedation.

Healthy Control Participants:

• No major medical illness, as determined by medical interview by study physician.
• As per parent report, subject is between the ages of 6 through 16 years at time of consent.
• As per parent report, subject is able to tolerate an MRI without sedation.

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Exclusion Criteria

All Participants:

• Full Scale IQ as documented to be below a standard score of <70 based upon the study IQ assessment completed after consent.
• As per self or parent report, completed any portion of the neuropsychological battery used in this study within the last year.
• MRI contraindications (e.g., implanted ferromagnetic devices, claustrophobia) as per radiology clinical operating procedures.
• As per self or parent report or medical record, currently taking medications that have CNS effects (i.e., antidepressants, neuroleptics, anti-seizure medications, drugs that affect blood pressure or heart rate, alpha-agonists, adrenergic blockers, lithium, sedating antihistamines, and some medications for the treatment of asthma).
• As per self or parent report, non-fluency in English language as demonstrated by current educational placement in a non-English-speaking classroom setting.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children Medulloblastoma Survivors	Resting state functional connectivity MRI (rs-fcMRI)	Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa
Children Medulloblastoma Survivors	Grooved Pegboard	Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa
Children Astrocytoma Survivors	Diffusion tensor imaging (DTI)	Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.
Children Astrocytoma Survivors	California Verbal Learning Test (CVLT-C)	Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.
Children Astrocytoma Survivors	Beery Test of Visual Motor Integration 6th edition	Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.
Age-Matched Healthy Children Controls	Beery Test of Visual Motor Integration 6th edition	-
Children Medulloblastoma Survivors	Wechsler Intelligence Scale for Children - 5th edition (WISC-V)	Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa
Children Astrocytoma Survivors	Wechsler Intelligence Scale for Children - 5th edition (WISC-V)	Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.
Age-Matched Healthy Children Controls	PedsQL Multidimensional Fatigue Scale	-
Children Medulloblastoma Survivors	California Verbal Learning Test (CVLT-C)	Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa
Children Medulloblastoma Survivors	MRI	Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa
Children Astrocytoma Survivors	Grooved Pegboard	Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.
Age-Matched Healthy Children Controls	Wechsler Intelligence Scale for Children - 5th edition (WISC-V)	-
Age-Matched Healthy Children Controls	Grooved Pegboard	-
Children Medulloblastoma Survivors	Diffusion tensor imaging (DTI)	Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa
Age-Matched Healthy Children Controls	California Verbal Learning Test (CVLT-C)	-
Age-Matched Healthy Children Controls	MRI	-
Children Medulloblastoma Survivors	Beery Test of Visual Motor Integration 6th edition	Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa
Children Medulloblastoma Survivors	PedsQL Multidimensional Fatigue Scale	Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa
Children Astrocytoma Survivors	Resting state functional connectivity MRI (rs-fcMRI)	Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.
Children Astrocytoma Survivors	PedsQL Multidimensional Fatigue Scale	Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.
Children Astrocytoma Survivors	MRI	Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.

Primary Outcome Measures

Name	Time	Method
Feasibilty which is the number of eligible survivors consented per month	2 years	The study is a pilot study to collect information on feasibility broadly defined. The feasibility indicators are primarily descriptive variables, including a careful monitoring of accrual rate (how many eligible survivors consented per month).

Trial Locations

Locations (4)

Columbia University; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States