Understanding the Late Effects of Surviving a Pediatric Brain Tumor

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Pediatric Brain Tumor; Brain Tumor; Pediatric Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT03208387

17-338

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

42 participants in 3 patient groups

Children Medulloblastoma Survivors

Description:

Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa

Treatment:

Behavioral: Wechsler Intelligence Scale for Children - 5th edition (WISC-V)

Behavioral: California Verbal Learning Test (CVLT-C)

Diagnostic Test: Diffusion tensor imaging (DTI)

Behavioral: PedsQL Multidimensional Fatigue Scale

Behavioral: Grooved Pegboard

Behavioral: Beery Test of Visual Motor Integration 6th edition

Diagnostic Test: MRI

Diagnostic Test: Resting state functional connectivity MRI (rs-fcMRI)

Children Astrocytoma Survivors

Description:

Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.

Treatment:

Behavioral: Wechsler Intelligence Scale for Children - 5th edition (WISC-V)

Behavioral: California Verbal Learning Test (CVLT-C)

Diagnostic Test: Diffusion tensor imaging (DTI)

Behavioral: PedsQL Multidimensional Fatigue Scale

Behavioral: Grooved Pegboard

Behavioral: Beery Test of Visual Motor Integration 6th edition

Diagnostic Test: MRI

Diagnostic Test: Resting state functional connectivity MRI (rs-fcMRI)

Age-Matched Healthy Children Controls

Treatment:

Behavioral: Wechsler Intelligence Scale for Children - 5th edition (WISC-V)

Behavioral: California Verbal Learning Test (CVLT-C)

Behavioral: PedsQL Multidimensional Fatigue Scale

Behavioral: Grooved Pegboard

Behavioral: Beery Test of Visual Motor Integration 6th edition

Diagnostic Test: MRI