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

Head and Neck Cancer Clinical Trial

— CogRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658731
• Other study ID #: J2255
• Secondary ID: IRB00331759
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2023
• Est. completion date: December 2035

Study information

• Verified date: June 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Sahaja Acharya, MD
• Phone: 202-537-4788
• Email: sachary7[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: December 2035
• Est. primary completion date: December 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 26 Years

Eligibility

1. STRATUM A

1. 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

2. 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

2. STRATUM B

1. 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

2. 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

3. STRATUM C

1. Eligibility Criteria

• must be aged 5 to <26 years of age

• must be able to complete research imaging without sedation

2. Exclusion Criteria

• must not have any major psychiatric, neurologic or medical diagnosis

Related Conditions & MeSH terms

• Brain Tumor
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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).

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Clark Charitable Foundation, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	baseline to two years
Secondary	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
Secondary	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
Secondary	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
Secondary	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