Back to resultsCognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients (CogRT)
Primary Purpose
Brain Tumor, Head and Neck Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
substructure informed planning
Neurocognitive Testing
MRI
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumor focused on measuring radiation therapy, pediatric
Eligibility Criteria
STRATUM A Eligibility Criteria aged 1 to <26 years of age tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit treatment must include radiation therapy (either proton or photon) patients must not have completed radiation therapy Exclusion Criteria pregnancy patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism STRATUM B Eligibility Criteria diagnosed with a brain tumor at <26 years of age received radiation to the brain as part of therapy time from radiation start to study enrollment is ≥ 2 years there has not been disease recurrence from time of most recent radiation treatment to study enrollment Exclusion Criteria patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism STRATUM C Eligibility Criteria must be aged 5 to <26 years of age must be able to complete research imaging without sedation Exclusion Criteria must not have any major psychiatric, neurologic or medical diagnosis
Sites / Locations
- Sibley Memorial HospitalRecruiting
- Johns Hopkins HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Other
Arm Label
Stratum A (new diagnosis, substructure informed radiation therapy)
Stratum B (patients ≥ 2 years after standard radiation therapy)
Stratum C (healthy controls matched to Stratum A)
Arm Description
Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.
Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago.
Healthy patients who are matched to Stratum A patients
Outcomes
Primary Outcome Measures
Number of plans that meet substructure-informed planning constraints
Number of plans that meet substructure-informed constraints (per protocol) divided by the total number of plans.
Secondary Outcome Measures
Cumulative incidence of local and distant tumor recurrence
Calculate the cumulative incidence of local and distant tumor recurrence. Local and tumor recurrence is determined by imaging and clinical symptoms.
Fractional anisotropy values
This outcome will measure changes in connection strength within brain networks. Fractional anisotropy values range from 0 to 1. Higher numbers are better.
compare the change in California Verbal Learning Test (CVLT) in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A.
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
compare the change in NIH toolbox scores in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A.
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
characterize longitudinal NIH toolbox scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
Full Information
NCT ID
NCT05658731
First Posted
October 31, 2022
Last Updated
May 18, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1. Study Identification
Unique Protocol Identification Number
NCT05658731
Brief Title
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
Acronym
CogRT
Official Title
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
December 2032 (Anticipated)
Study Completion Date
December 2035 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients.
Patients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study.
Survivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed.
Healthy children will also be enrolled and have research MRIs done.
The researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Head and Neck Cancer
Keywords
radiation therapy, pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stratum A: patients with new diagnosis of brain or head and neck cancer who will be undergoing radiation therapy with substructure informed planning
Stratum B: patients ≥ 2 years from radiation therapy for brain tumor who underwent standard planning radiation therapy
Stratum C: healthy controls matched to Stratum A patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
338 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stratum A (new diagnosis, substructure informed radiation therapy)
Arm Type
Experimental
Arm Description
Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.
Arm Title
Stratum B (patients ≥ 2 years after standard radiation therapy)
Arm Type
Other
Arm Description
Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago.
Arm Title
Stratum C (healthy controls matched to Stratum A)
Arm Type
Other
Arm Description
Healthy patients who are matched to Stratum A patients
Intervention Type
Radiation
Intervention Name(s)
substructure informed planning
Intervention Description
Radiation Therapy with substructure informed planning determined by the PI.
Intervention Type
Other
Intervention Name(s)
Neurocognitive Testing
Intervention Description
California Verbal Learning Test (CVLT) and other cognition assessments.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).
Primary Outcome Measure Information:
Title
Number of plans that meet substructure-informed planning constraints
Description
Number of plans that meet substructure-informed constraints (per protocol) divided by the total number of plans.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Cumulative incidence of local and distant tumor recurrence
Description
Calculate the cumulative incidence of local and distant tumor recurrence. Local and tumor recurrence is determined by imaging and clinical symptoms.
Time Frame
up to 5 years after treatment
Title
Fractional anisotropy values
Description
This outcome will measure changes in connection strength within brain networks. Fractional anisotropy values range from 0 to 1. Higher numbers are better.
Time Frame
baseline to two years
Title
compare the change in California Verbal Learning Test (CVLT) in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A.
Description
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
Time Frame
baseline to 3 years
Title
compare the change in NIH toolbox scores in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A.
Description
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
Time Frame
baseline to 5 years
Title
characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation
Description
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
Time Frame
baseline to 5 years
Title
characterize longitudinal NIH toolbox scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation
Description
Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.
Time Frame
baseline to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
STRATUM A
Eligibility Criteria
aged 1 to <26 years of age
tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit
treatment must include radiation therapy (either proton or photon)
patients must not have completed radiation therapy
Exclusion Criteria
pregnancy
patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
STRATUM B
Eligibility Criteria
diagnosed with a brain tumor at <26 years of age
received radiation to the brain as part of therapy
time from radiation start to study enrollment is ≥ 2 years
there has not been disease recurrence from time of most recent radiation treatment to study enrollment
Exclusion Criteria
patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
STRATUM C
Eligibility Criteria
must be aged 5 to <26 years of age
must be able to complete research imaging without sedation
Exclusion Criteria
must not have any major psychiatric, neurologic or medical diagnosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sahaja Acharya, MD
Phone
202-537-4788
Email
sachary7@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Lowe
Phone
410-955-8652
Email
katielowe@jhmi.edu
Facility Information:
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
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