Observational Trial of the Impact of Radiation Dose in Children With Brain and Skull Base Tumors.

Sponsor

Baptist Health South Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT03972514

Collaborator

Nicklaus Children's Hospital f/k/a Miami Children's Hospital (Other)

Enrollment

Location

131.8

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, observational clinical trial investigating the morphological and volumetric changes in the brain following cranial Radiation Therapy in pediatric patients with brain or skull base tumors.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor Brain Cancer Skull Base Tumor

Detailed Description

Brain injury is a known complication of cranial RT, but little is known about the factors that predispose patients to such injury. The brain is a highly interconnected organ linked through neuronal connections, cellular migration, and vascular supply and is endowed with exquisitely radiosensitive stem cell niches responsible for neuro-regeneration. To date, the effects of brain radiation have been quantified in few brain substructures. The majority of publications on this topic have focused on regions receiving higher doses. Even low dose radiation exposure, however has global implications on brain development and function, and its effects are less well studied. It is increasingly recognized that radiation damage to one brain region can potentially affect brain development more broadly. This has important implications on RT planning and the potential for understanding its long-term effects.

In this protocol, the investigators aim to measure serum inflammatory cytokine levels and other molecular biomarkers at baseline and post-exposure in an exploratory manner to investigate potential associations with the risk of developing volumetric changes in the brain and radiation-induced toxicities.

This study will observe sixty (60) patients under the age of 21 with brain or base of skull tumor. The study team will observe the effect of radiation therapy per the study protocol versus standard of care.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Observational Trial of the Impact of Radiation Dose on Brain Morphology, Volumetric Changes, Endocrine Function, and Neurocognitive Function Following Cranial Radiation Therapy in Children With Brain and Skull Base Tumors.

Actual Study Start Date :

Mar 8, 2019

Anticipated Primary Completion Date :

Mar 1, 2030

Anticipated Study Completion Date :

Mar 1, 2030

Outcome Measures

Primary Outcome Measures

Measure temporal changes in brain volumes [Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years]
Measure temporal changes in brain volumes after exposure to therapeutic RT and to correlate these changes with absorbed dose.
Measure temporal changes in morphometry [Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years]
Measure temporal changes in morphometry after exposure to therapeutic RT and to correlate these changes with absorbed dose.

Secondary Outcome Measures

Morphometric changes in the brain [Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years]
The secondary aims for this study are to correlate morphometric changes in the brain with the development of late treatment-related effects, including measurable neurocognitive, endocrine, and quality of life effects.

Other Outcome Measures

Measure molecular biomarkers [Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years]
Serum pro-inflammatory and anti-inflammatory cytokine levels will be measured at baseline and during follow-up as part of an exploratory hypothesis-generating correlate study to analyze potential associations with risk of radiation-induced toxicities and volumetric changes in the brain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient (parent) must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment. Written assent will be obtained as per Institutional guidelines.
Patients (Age equal to or less than 35 years old) that are planned to receive photon or proton RT to the brain according to standard of care are eligible to participate.
Patients that are planned to receive fractionated RT at 1.2-2.0 Gy RBE dose per fraction per standard of care are eligible to participate. If patients are planned to receive an alternative dose/fractionation regimen, then they should be treated according to standard of care and should not be enrolled.
Zubrod/Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1