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

Обзор

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.

Вмешательства

• Лучевая терапия substructure informed planning
  Radiation Therapy with substructure informed planning determined by the PI.
• Другое Neurocognitive Testing
  California Verbal Learning Test (CVLT) and other cognition assessments.
• Диагностический тест MRI
  Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).

Первичные конечные точки

• Number of plans that meet substructure-informed planning constraints [Срок оценки: 1 month]

Вторичные конечные точки (6)

• Cumulative incidence of local and distant tumor recurrence [Срок оценки: up to 5 years after treatment]
• Fractional anisotropy values [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: baseline to 5 years]
• characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation [Срок оценки: baseline to 5 years]
• characterize longitudinal NIH toolbox scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation [Срок оценки: baseline to 5 years]

Критерии участия

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Sibley Memorial Hospital — Washington D.C.
• Johns Hopkins Hospital — Baltimore

Идентификаторы

NCT: NCT05658731 · J2255 · IRB00331759

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗