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Active Not RecruitingNCT03208387

Understanding the Late Effects of Surviving a Pediatric Brain Tumor

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
42 (actual)
Sponsor
Memorial Sloan Kettering Cancer Center · Academic / Other
Sex
All
Age
6 Years – 16 Years
Healthy volunteers

Summary

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

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTDiffusion 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.
DIAGNOSTIC_TESTResting 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.
BEHAVIORALWechsler 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.
BEHAVIORALCalifornia Verbal Learning Test (CVLT-C)Validated measure of verbal learning and memory for those between the ages of 5:0 and 16:11.
BEHAVIORALBeery Test of Visual Motor Integration 6th editionMeasure designed to assess visual-motor functioning of subjects between the ages of 2-99 years old by copying designs using paper and pencil.
BEHAVIORALGrooved PegboardThis is a standard assessment of fine motor functioning and dexterity by asking the subject to place metal pegs into holes on a board.
BEHAVIORALPedsQL Multidimensional Fatigue ScaleDesigned 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_TESTMRIImages 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)

Timeline

Start date
2017-06-28
Primary completion
2026-06-01
Completion
2026-06-01
First posted
2017-07-05
Last updated
2025-09-12

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03208387. Inclusion in this directory is not an endorsement.