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

Brain Tumor Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03972514
• Other study ID #: 2018-LLB-HALL-001
• Status: Active, not recruiting
• Start date: March 8, 2019
• Est. completion date: March 2030

Study information

• Verified date: June 2023
• Source: Baptist Health South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 2030
• Est. primary completion date: March 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 35 Years

Eligibility

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

Exclusion Criteria:

• 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%

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Brain Tumor
• Neoplasms
• Skull Base Neoplasms
• Skull Base Tumor

Locations

Country	Name	City	State
United States	Miami Cancer Institute at Baptist Health South Florida	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Baptist Health South Florida	Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measure molecular biomarkers	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.	Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
Primary	Measure temporal changes in brain volumes	Measure temporal changes in brain volumes after exposure to therapeutic RT and to correlate these changes with absorbed dose.	Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
Primary	Measure temporal changes in morphometry	Measure temporal changes in morphometry after exposure to therapeutic RT and to correlate these changes with absorbed dose.	Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
Secondary	Morphometric changes in the brain	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.	Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years

External Links

•   Miami Cancer Institute Website