Brain TumorNCT03208387
Understanding the Late Effects of Surviving a Pediatric Brain Tumor
An observational study of Brain Tumor and Pediatric Brain Tumor, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Brain Tumor, Pediatric Brain Tumor, Pediatric Cancer
- What is being tested?
- Diffusion tensor imaging (DTI), Resting state functional connectivity MRI (rs-fcMRI) and Wechsler Intelligence Scale for Children - 5th edition (WISC-V)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Jun 2017to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Child
Study population: Participants will be recruited at MSK and three participating sites (Columbia University, University of Washington and University of Texas Southwestern).
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Columbia University
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Biological Substrates of Impaired Neurocognitive Functioning: Understanding the Late Effects of Surviving a Pediatric Brain Tumor
The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.
- Conditions
- Brain Tumor, Pediatric Brain Tumor, Pediatric Cancer
- Being tested
- 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
- Keywords
- 17-338, Cognitive function, Behavioral function
- Medical subject headings
- Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion tensor imaging (DTI)Diagnostic test
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)Diagnostic test
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.
Wechsler Intelligence Scale for Children - 5th edition (WISC-V)Behavioural
Also called 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)Behavioural
Also called 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 editionBehavioural
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 PegboardBehavioural
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 ScaleBehavioural
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).
MRIDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| Children Medulloblastoma Survivors | Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa Receives: 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 | |
| Children Astrocytoma Survivors | Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation. Receives: 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 | |
| Age-Matched Healthy Children Controls | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start28 Jun 2017
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, University of Washington, University of Texas, Rutgers University
- Responsible party
- Sponsor
- Investigators
- Stephen Sands, PsyD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208387
- Sponsor's protocol ID
- 17-338
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2017
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Substrates of Impaired Neurocognitive Functioning: Understanding the Late Effects of Surviving a Pediatric Brain Tumor
- ClinicalTrials.gov ID
- NCT03208387
- Acronym / sponsor ID
- 17-338
- Conditions
- Brain Tumor, Pediatric Brain Tumor, Pediatric Cancer
- Keywords
- 17-338, Cognitive function, Behavioral function
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Columbia University, University of Washington, University of Texas, Rutgers University
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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: MRIParticipants 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: MRIParticipants 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 |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Participants will be recruited at MSK and three participating sites (Columbia University, University of Washington and University of Texas Southwestern).
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Children Astrocytoma Survivors, Children Medulloblastoma Survivors |
| 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. | Diagnostic test | Children Astrocytoma Survivors, Children Medulloblastoma Survivors |
| Wechsler Intelligence Scale for Children - 5th edition (WISC-V)Also: WISC-VWill gather IQ data and is the gold standard for IQ assessment for those between the ages of 6:0 and 16:11 years. | Behavioural | Age-Matched Healthy Children Controls, Children Astrocytoma Survivors, Children Medulloblastoma Survivors |
| California Verbal Learning Test (CVLT-C)Also: CVLT-CValidated measure of verbal learning and memory for those between the ages of 5:0 and 16:11. | Behavioural | Age-Matched Healthy Children Controls, Children Astrocytoma Survivors, Children Medulloblastoma Survivors |
| Beery 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. | Behavioural | Age-Matched Healthy Children Controls, Children Astrocytoma Survivors, Children Medulloblastoma Survivors |
| Grooved PegboardThis is a standard assessment of fine motor functioning and dexterity by asking the subject to place metal pegs into holes on a board. | Behavioural | Age-Matched Healthy Children Controls, Children Astrocytoma Survivors, Children Medulloblastoma Survivors |
| PedsQL 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). | Behavioural | Age-Matched Healthy Children Controls, Children Astrocytoma Survivors, Children Medulloblastoma Survivors |
| MRIImages 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) | Diagnostic test | Age-Matched Healthy Children Controls, Children Astrocytoma Survivors, Children Medulloblastoma Survivors |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Sands, PsyD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Pediatric Brain Tumor, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibilty which is the number of eligible survivors consented per month (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.