Brain TumorCogRTNCT05658731
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
A study testing substructure informed planning, Neurocognitive Testing and MRI in people with Brain Tumor and Head and Neck Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumor, Head and Neck Cancer
- What is being tested?
- substructure informed planning, Neurocognitive Testing and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 May 2023to Dec 2035
- Phase
- Interventional
- 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 1 year to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
- Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
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.
Read more
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.
- Conditions
- Brain Tumor, Head and Neck Cancer
- Being tested
- substructure informed planning, Neurocognitive Testing, MRI
- Keywords
- radiation therapy, pediatric
- Medical subject headings
- Brain Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
substructure informed planningRadiation
Radiation Therapy with substructure informed planning determined by the PI.
Neurocognitive TestingOther
California Verbal Learning Test (CVLT) and other cognition assessments.
MRIDiagnostic test
Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).
| Study group | Role | What they receive |
|---|---|---|
| Stratum A (new diagnosis, substructure informed radiation therapy) | Experimental | Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures. Receives: Radiation: substructure informed planning; Other: Neurocognitive Testing; Diagnostic Test: MRI |
| Stratum B (patients ≥ 2 years after standard radiation therapy) | Other | Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago. Receives: Other: Neurocognitive Testing; Diagnostic Test: MRI |
| Stratum C (healthy controls matched to Stratum A) | Other | Healthy patients who are matched to Stratum A patients Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (6)
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.
Measured: up to 5 years after treatment
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.
Measured: baseline to two years
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.
Measured: baseline to 3 years
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.
Measured: baseline to 5 years
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.
Measured: baseline to 5 years
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.
Measured: baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start17 May 2023
- Primary completionDec 2032 (estimated)
- Study completionDec 2035 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Clark Charitable Foundation Inc.
- Responsible party
- Sponsor
- Investigators
- Sahaja Acharya, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658731
- Sponsor's protocol ID
- J2255
- Other IDs
- IRB00331759
- Acronym
- CogRT
- Status last verified
- Jun 2026
- First submitted
- 31 Oct 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05658731
- Acronym / sponsor ID
- CogRT / J2255
- Conditions
- Brain Tumor, Head and Neck Cancer
- Keywords
- radiation therapy, pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- United States Department of Defense, Clark Charitable Foundation Inc.
- Study start
- 17 May 2023 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 21 Dec 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Stratum A (new diagnosis, substructure informed radiation therapy) | Experimental | Radiation: substructure informed planning, Other: Neurocognitive Testing, Diagnostic Test: MRIPatients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures. |
| Stratum B (patients ≥ 2 years after standard radiation therapy) | Other | Other: Neurocognitive Testing, Diagnostic Test: MRIPatients who completed radiation therapy under standard planning procedures ≥ 2 years ago. |
| Stratum C (healthy controls matched to Stratum A) | Other | Diagnostic Test: MRIHealthy patients who are matched to Stratum A patients |
Who may qualify
- Ages
- 1 year to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| substructure informed planningRadiation Therapy with substructure informed planning determined by the PI. | Radiation | Stratum A (new diagnosis, substructure informed radiation therapy) |
| Neurocognitive TestingCalifornia Verbal Learning Test (CVLT) and other cognition assessments. | Other | Stratum A (new diagnosis, substructure informed radiation therapy), Stratum B (patients ≥ 2 years after standard radiation therapy) |
| MRIMagnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI). | Diagnostic test | 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) |
Primary outcome
Number of plans that meet substructure-informed planning constraints
Time frame: 1 month
Number of plans that meet substructure-informed constraints (per protocol) divided by the total number of plans.
6 secondary outcomes
Cumulative incidence of local and distant tumor recurrence
Time frame: up to 5 years after treatment
Fractional anisotropy values
Time frame: baseline to two years
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.
Time frame: baseline to 3 years
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.
Time frame: baseline to 5 years
characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation
Time frame: baseline to 5 years
characterize longitudinal NIH toolbox scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation
Time frame: baseline to 5 years
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 29 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Sahaja Acharya, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing substructure informed planning, Neurocognitive Testing and MRI in people with Brain Tumor and Head and Neck Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 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?
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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Sahaja Acharya, MD (202-537-4788, sachary7@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of plans that meet substructure-informed planning constraints (time frame: 1 month). 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 29 Jun 2026.