Biological Substrates of Impaired Neurocognitive Functioning: Understanding the Late Effects of Surviving a Pediatric Brain Tumor
| Registry | NCT03208387 |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 42 (Actual) |
| Sponsor | Memorial Sloan Kettering Cancer Center (Other); collaborators: Columbia University, University of Washington, University of Texas, Rutgers University |
| Conditions | Brain Tumor, Pediatric Brain Tumor, Pediatric Cancer |
| Interventions | Diffusion tensor imaging (DTI), Resting state functional connectivity MRI (rs-fcMRI), Wechsler Intelligence Scale for Children - 5th edition (WISC-V), California Verbal Learning Test (CVLT-C), Beery Test of Visual Motor Integration 6th edition, Grooved Pegboard, PedsQL Multidimensional Fatigue Scale, MRI (Diagnostic test, behavioral) |
| Dates | start 2017-06-28, primary completion 2027-06-01 (estimated), completion 2027-06-01 (estimated), first posted 2017-07-05, last updated 2026-07-02 |
| Locations | 4 sites in United States |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Brain Tumor All trials for Pediatric Brain Tumor All trials of Diffusion tensor imaging (DTI) All trials of Resting state functional connectivity MRI (rs-fcMRI)
The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Children Medulloblastoma Survivors | 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: Grooved Pegboard; Behavioral: PedsQL Multidimensional Fatigue Scale; Diagnostic Test: MRI | Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa | |
| Children Astrocytoma Survivors | 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: Grooved Pegboard; Behavioral: PedsQL Multidimensional Fatigue Scale; Diagnostic Test: MRI | Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation. | |
| Age-Matched Healthy Children Controls | 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: Grooved Pegboard; Behavioral: PedsQL Multidimensional Fatigue Scale; Diagnostic Test: MRI |
Sex: All, ages: 6 Years to 16 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |