CogRT: Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05658731
Collaborator
(none)
338
2
3
108
169
1.6

Study Details

Study Description

Brief Summary

The goal of this trial is to see if it is possible to better plan how radiation therapy is delivered to different parts of the brain 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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: substructure informed planning
  • Other: Neurocognitive Testing
  • Diagnostic Test: MRI
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
338 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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 patientsStratum 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)
Primary Purpose:
Treatment
Official Title:
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2030
Anticipated Study Completion Date :
Jan 1, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stratum A (new diagnosis, substructure informed radiation therapy)

Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.

Radiation: substructure informed planning
Radiation Therapy with substructure informed planning determined by the PI,

Other: Neurocognitive Testing
California Verbal Learning Test (CVLT) and other cognition assessments.

Diagnostic Test: MRI
Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).

Other: Stratum B (patients ≥ 2 years after standard radiation therapy)

Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago.

Other: Neurocognitive Testing
California Verbal Learning Test (CVLT) and other cognition assessments.

Diagnostic Test: MRI
Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).

Other: Stratum C (healthy controls matched to Stratum A)

Healthy patients who are matched to Stratum A patients

Other: Neurocognitive Testing
California Verbal Learning Test (CVLT) and other cognition assessments.

Diagnostic Test: MRI
Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).

Outcome Measures

Primary Outcome Measures

  1. Number of plans that meet substructure-informed planning constraints [1 month]

    Number of plans that meet substructure-informed constraints (per protocol) divided by the total number of plans.

Secondary Outcome Measures

  1. Cumulative incidence of local and distant tumor recurrence [up to 5 years after treatment]

    Calculate the cumulative incidence of local and distant tumor recurrence. Local and tumor recurrence is determined by imaging and clinical symptoms.

  2. Fractional anisotropy values [baseline to two years]

    This outcome will measure changes in connection strength within brain networks. Fractional anisotropy values range from 0 to 1. Higher numbers are better.

  3. 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. [baseline to 3 years]

    Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.

  4. compare the change in Cogstate scores in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A. [baseline to 5 years]

    Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.

  5. characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation [baseline to 5 years]

    Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.

  6. characterize longitudinal Cogstate scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation [baseline to 5 years]

    Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 26 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  1. STRATUM A

  2. 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

  1. 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

  1. STRATUM B

  2. 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

  1. 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
  1. STRATUM C

  2. Eligibility Criteria

  • must be aged 5 to <26 years of age

  • must be able to complete research imaging without sedation

  1. Exclusion Criteria
  • must not have any major psychiatric, neurologic or medical diagnosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sibley Memorial Hospital Washington District of Columbia United States 20016
2 Johns Hopkins Hospital Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier:
NCT05658731
Other Study ID Numbers:
  • J2255
First Posted:
Dec 21, 2022
Last Update Posted:
Dec 21, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2022