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.
Verified date | June 2023 |
Source | Baptist Health South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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% |
Country | Name | City | State |
---|---|---|---|
United States | Miami Cancer Institute at Baptist Health South Florida | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Baptist Health South Florida | Nicklaus Children's Hospital f/k/a Miami Children's Hospital |
United States,
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 |
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