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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00331759 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Clark Charitable Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Stratum B (patients ≥ 2 years after standard radiation therapy) | Other | Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago. |
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| Stratum C (healthy controls matched to Stratum A) | Other | Healthy patients who are matched to Stratum A patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| substructure informed planning | Radiation | Radiation Therapy with substructure informed planning determined by the PI. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 5 years after treatment |
| Fractional anisotropy values |
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STRATUM A
Eligibility Criteria
Exclusion Criteria
STRATUM B
Eligibility Criteria
Exclusion Criteria
STRATUM C
Eligibility Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sahaja Acharya, MD | Contact | 202-537-4788 | sachary7@jhmi.edu | |
| Katie Lowe | Contact | 410-955-8652 | katielowe@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sahaja Acharya, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Recruiting | Washington D.C. | District of Columbia | 20016 | United States | |
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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
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| Neurocognitive Testing | Other | California Verbal Learning Test (CVLT) and other cognition assessments. |
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| MRI | Diagnostic Test | Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI). |
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This outcome will measure changes in connection strength within brain networks. Fractional anisotropy values range from 0 to 1. Higher numbers are better. |
| 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. | 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. | 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. | 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. | baseline to 5 years |
| Johns Hopkins Hospital |
| Recruiting |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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