Clinical trial · Observational
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.
NCT03972514CI-TRIAL-00117893active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Skull Base Tumor | Skull Base Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Measure temporal changes in brain volumes
- timeFrame
- Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
- description
- Measure temporal changes in brain volumes after exposure to therapeutic RT and to correlate these changes with absorbed dose.
- measure
- Measure temporal changes in morphometry
- timeFrame
- Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
- description
- Measure temporal changes in morphometry after exposure to therapeutic RT and to correlate these changes with absorbed dose.
Secondary outcomes (1)
- measure
- Morphometric changes in the brain
- timeFrame
- Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 35 Years
Show eligibility criteria text
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%
References
Publications (0)
Data not yet available
No reference posted for this study.