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

Running, not enrolling

Conditions studied: Brain Tumor, Brain Cancer, Skull Base Tumor

In brief

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.

Key facts

Study ID

NCT03972514

Run by

Baptist Health South Florida

People needed

60

Starts

2019-03-08

Expected to finish

2030-03-01

Last updated by the study team

2026-07-14

Who can join

Age: 1 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patient cannot undergo MRI without contrast as per standard of care
• Patient and family do not speak English or Spanish
• Patient receiving treatment with non-curative intent
• Patients with an expected 3-year overall survival less than 50%

Where it is running

• Miami Cancer Institute at Baptist Health South Florida — Miami, Florida, United States

Full record on ClinicalTrials.gov

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