- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02914067
Cognitive Biomarkers in Pediatric Brain Tumor Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephanie Perkins, M.D.
- Phone Number: 314-273-2931
- Email: sperkins@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Sub-Investigator:
- Joshua Shimony, M.D., Ph.D.
-
Principal Investigator:
- Stephanie Perkins, M.D.
-
Contact:
- Stephanie Perkins, M.D.
- Phone Number: 314-273-2931
- Email: sperkins@wustl.edu
-
Sub-Investigator:
- David Limbrick, M.D., Ph.D.
-
Sub-Investigator:
- Josh Rubin, M.D., Ph.D.
-
Sub-Investigator:
- Dennis Barbour, M.D., Ph.D.
-
Sub-Investigator:
- Scott Marek, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Cohort 1 (30 patients will be enrolled to this cohort)
Inclusion Criteria:
- Between 4 and 18 years of age, inclusive
- Newly diagnosed primary brain tumor of any location and any histology
- Life expectancy of at least one year
- Able to understand and willing to consent or assent to the research proposed, along with consent of legal guardian(s) if applicable
Exclusion Criteria:
- Presence of visual impairment to an extent that the patient is unable to complete the computer testing
- Contraindication to MRI scan (i.e. due to cardiac pacemaker)
- Programmable Shunt
Cohort 2 (150 patients will enrolled to this cohort. This may include some or all of the patients enrolled to Cohort 1.)
Inclusion Criteria:
- Between 4 and 18 years of age, inclusive
- Previous diagnosis of a posterior fossa brain tumor; patients who are either undergoing active treatment for posterior fossa tumor or who have completed treatment will be eligible for study enrollment
- Life expectancy of at least one year
- Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable
Exclusion Criteria:
- Presence of visual impairment to an extent that the patient is unable to complete the computer testing
- Contraindication to MRI scan (i.e. due to cardiac pacemaker)
Cohort 3 (20 patients will be enrolled to this cohort. This may include some or all of the patients enrolled to Cohort 1) Inclusion Criteria
- Between 4 and 18 years of age, inclusive
- Previous diagnosis of a posterior fossa brain tumor
- Clinical diagnosis of post-operative posterior fossa syndrome
- Inability to complete NIH Toolbox
- Life expectancy of at least one year
- Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable
Exclusion Criteria
- Contraindication to MRI scan (i.e. due to cardiac pacemaker)
Cohort 4 (50 Patients will be enrolled to Cohort 4. This will include patients previously enrolled on Cohorts 1-3 above.)
Inclusion Criteria
- Between 12-30 years of age, inclusive
- Diagnosis of a brain tumor >3 years prior to study enrollment
- Life expectancy of at least one year
- Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable
- Patient must be able to complete a 1 hour MRI scan without sedation
Exclusion Criteria
- Contraindiciation to MRI scan (i.e. due to cardian pacemaker)
- Presence of dental braces or programmable shunt
- Patient requires sedation for MRI scan
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
|
The imaging protocols will be a combined version of a standard of care (SOC) protocol with a research portion.
The SOC portion of the pre-surgical scans includes a 3D T2-weighted (T2w) scans and 3D pre- and post-contrast T1-weighted (T1w) images, both at high resolution (1.0 mm3) for use in the intraoperative navigation system.
This scan also includes a DTI portion for definition of fiber bundles of interest.
The SOC portion of the post-surgical scans includes transverse FLAIR and post-contrast T1w images in all 3 planes.
The research portion of the scan will be identical at all 3 time points and include 15 min of rsfcMRI during which the non-sedated subjects will be asked to stay still and awake while looking at a fixation cross
|
Experimental: Cohort 2
|
The imaging protocols will be a combined version of a standard of care (SOC) protocol with a research portion.
The SOC portion of the pre-surgical scans includes a 3D T2-weighted (T2w) scans and 3D pre- and post-contrast T1-weighted (T1w) images, both at high resolution (1.0 mm3) for use in the intraoperative navigation system.
This scan also includes a DTI portion for definition of fiber bundles of interest.
The SOC portion of the post-surgical scans includes transverse FLAIR and post-contrast T1w images in all 3 planes.
The research portion of the scan will be identical at all 3 time points and include 15 min of rsfcMRI during which the non-sedated subjects will be asked to stay still and awake while looking at a fixation cross
|
Experimental: Cohort 3
|
The imaging protocols will be a combined version of a standard of care (SOC) protocol with a research portion.
The SOC portion of the pre-surgical scans includes a 3D T2-weighted (T2w) scans and 3D pre- and post-contrast T1-weighted (T1w) images, both at high resolution (1.0 mm3) for use in the intraoperative navigation system.
This scan also includes a DTI portion for definition of fiber bundles of interest.
The SOC portion of the post-surgical scans includes transverse FLAIR and post-contrast T1w images in all 3 planes.
The research portion of the scan will be identical at all 3 time points and include 15 min of rsfcMRI during which the non-sedated subjects will be asked to stay still and awake while looking at a fixation cross
|
Experimental: Cohort 4 Arm A
Undergo the following MRI images: RSFC MRI, T2/T1 MRI, and DTI.
|
The imaging protocols will be a combined version of a standard of care (SOC) protocol with a research portion.
The SOC portion of the pre-surgical scans includes a 3D T2-weighted (T2w) scans and 3D pre- and post-contrast T1-weighted (T1w) images, both at high resolution (1.0 mm3) for use in the intraoperative navigation system.
This scan also includes a DTI portion for definition of fiber bundles of interest.
The SOC portion of the post-surgical scans includes transverse FLAIR and post-contrast T1w images in all 3 planes.
The research portion of the scan will be identical at all 3 time points and include 15 min of rsfcMRI during which the non-sedated subjects will be asked to stay still and awake while looking at a fixation cross
|
Experimental: Cohort 4 Arm B
|
The imaging protocols will be a combined version of a standard of care (SOC) protocol with a research portion.
The SOC portion of the pre-surgical scans includes a 3D T2-weighted (T2w) scans and 3D pre- and post-contrast T1-weighted (T1w) images, both at high resolution (1.0 mm3) for use in the intraoperative navigation system.
This scan also includes a DTI portion for definition of fiber bundles of interest.
The SOC portion of the post-surgical scans includes transverse FLAIR and post-contrast T1w images in all 3 planes.
The research portion of the scan will be identical at all 3 time points and include 15 min of rsfcMRI during which the non-sedated subjects will be asked to stay still and awake while looking at a fixation cross
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identify reliable peri-diagnostic estimators of cognition as measured by neurocognitive testing
Time Frame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
|
Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
|
|
Identify reliable peri-diagnostic estimators of cognition as measured by advanced resting-state functional connectivity MRI (rsfcMRI) data
Time Frame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
|
Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
|
|
Predictors of cognitive recovery in children as determined by multiplexed analyses of a combination of potential biomarkers across multiple modalities (rsfcMRI, structural MRI, NIH Toolbox, patient demographics, treatment information)
Time Frame: Up to 27 months
|
As dictated by information theory, properly combining predictors across modalities must increase the accuracy of the prediction algorithm, unless a given modality contains no information about the question of interest (in this case, long-term cognitive outcomes).
|
Up to 27 months
|
Identify reliable peri-diagnostic estimators of brain function as measured by neurocognitive testing
Time Frame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
|
Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
|
|
Identify reliable peri-diagnostic estimators of brain function as measured by advanced resting-state functional connectivity MRI (rsfcMRI) data
Time Frame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
|
Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stephanie Perkins, M.D., Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201609023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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