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Understanding the Late Effects of Surviving a Pediatric Brain Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208387
Recruitment Status : Active, not recruiting
First Posted : July 5, 2017
Last Update Posted : May 13, 2020
Sponsor:
Collaborators:
Columbia University
University of Washington
University of Texas
Rutgers University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Brain Tumor Pediatric Brain Tumor Pediatric Cancer 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

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biological Substrates of Impaired Neurocognitive Functioning: Understanding the Late Effects of Surviving a Pediatric Brain Tumor
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Group/Cohort Intervention/treatment
Children Medulloblastoma Survivors
Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa
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.

Diagnostic Test: 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.
Other Name: WISC-V

Behavioral: California Verbal Learning Test (CVLT-C)
Validated measure of verbal learning and memory for those between the ages of 5:0 and 16:11.
Other Name: CVLT-C

Behavioral: 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.

Behavioral: 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.

Behavioral: 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)

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

Diagnostic Test: 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.
Other Name: WISC-V

Behavioral: California Verbal Learning Test (CVLT-C)
Validated measure of verbal learning and memory for those between the ages of 5:0 and 16:11.
Other Name: CVLT-C

Behavioral: 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.

Behavioral: 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.

Behavioral: 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)

Age-Matched Healthy Children Controls 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.
Other Name: WISC-V

Behavioral: California Verbal Learning Test (CVLT-C)
Validated measure of verbal learning and memory for those between the ages of 5:0 and 16:11.
Other Name: CVLT-C

Behavioral: 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.

Behavioral: 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.

Behavioral: 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)




Primary Outcome Measures :
  1. Feasibilty which is the number of eligible survivors consented per month [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited at MSK and three participating sites (Columbia University, University of Washington and University of Texas Southwestern).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208387


Locations
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United States, New York
Columbia University
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Columbia University
University of Washington
University of Texas
Rutgers University
Investigators
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Principal Investigator: Stephen Sands, PsyD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03208387    
Other Study ID Numbers: 17-338
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
17-338
Cognitive function
Behavioral function
Additional relevant MeSH terms:
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Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases