Understanding the Late Effects of Surviving a Pediatric Brain Tumor

Brain Tumor Clinical Trial

Official title:

Biological Substrates of Impaired Neurocognitive Functioning: Understanding the Late Effects of Surviving a Pediatric Brain Tumor

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03208387
• Other study ID #: 17-338
• Status: Active, not recruiting
• Start date: June 28, 2017
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Neoplasms
• Pediatric Brain Tumor
• Pediatric Cancer

Intervention

Diagnostic Test:
• Diffusion tensor imaging (DTI)
DTI quantifies the degree to which water diffuses in different directions through a given brain region. The use of DTI as an in vivo index of the integrity of white matter has been applied to many disease states using several proprietary and open-source software programs (e.g. FSL 5.0). DTI tractography, employed via toolboxes such as Probtrackx within the FSL 5.0, allows the identification of white matter tracts connecting cortical and subcortical regions of interest. Furthermore, structural connectivity as measured with DTI does not duplicate functional connectivity as measure with rs-fcMRI, but rather provides complimentary perspectives.
• Resting state functional connectivity MRI (rs-fcMRI)
rs-fcMRI is a relatively new neuroimaging technique that has been applied to studying multiple clinical populations including ADHD, schizophrenia, major depressive disorder, and other neurological disorders. The approach exploits measurement of changes in brain blood oxygenation (BOLD) as is employed in task based functional MRI (measuring changes in focal cortical vascular oxygenation when engaged in a defined task, e.g. motor movement). Neuroimaging data will be collected as soon as possible (can be the same day), for up to 6 weeks.

Behavioral:
• Wechsler Intelligence Scale for Children - 5th edition (WISC-V)
Will gather IQ data and is the gold standard for IQ assessment for those between the ages of 6:0 and 16:11 years.
• California Verbal Learning Test (CVLT-C)
Validated measure of verbal learning and memory for those between the ages of 5:0 and 16:11.
• Beery Test of Visual Motor Integration 6th edition
Measure designed to assess visual-motor functioning of subjects between the ages of 2-99 years old by copying designs using paper and pencil.
• Grooved Pegboard
This is a standard assessment of fine motor functioning and dexterity by asking the subject to place metal pegs into holes on a board.
• PedsQL Multidimensional Fatigue Scale
Designed to measure fatigue in pediatric patients (ages 5-17 years) and is comprised of the General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items) and Cognitive Fatigue Scale (6 items).

Diagnostic Test:
• MRI
Images will be acquired on a 3.0 Tesla MRI scanner at each of the four study sites. At MSK, resting state fMRI data will be obtained using a 3T GE scanner with an 8-channel head coil (Discovery 750w DV25)

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Columbia University	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Columbia University, Rutgers University, University of Texas, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibilty which is the number of eligible survivors consented per month	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).	2 years

External Links

•   Memorial Sloan Kettering Cancer Center