NCT03972514

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

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.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: All
• Age: 1 Year – 35 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Brain Tumor
• Brain Cancer
• Skull Base Tumor

Timeline

• Start date: 2019-03-08
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2019-06-03
• Last updated: 2025-07-30

Locations

1 site across 1 country: United States