Brain TumorNCT03972514
Observational Trial of the Impact of Radiation Dose in Children With Brain and Skull Base Tumors.
An observational study of Brain Tumor and Brain Cancer, run by Baptist Health South Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 35 years
- Conditions the study is for
- Brain Tumor, Brain Cancer, Skull Base Tumor
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study sample size will be 60 patients. This sample size was selected to ensure an adequate distribution of primary tumor diagnoses and dosimetric variation in major brain substructures treated based on tumor location/brain regions treated. The estimated case distribution based on historical data from 2007-2015 will be: Craniopharyngioma 20%, Ependymoma 20%, Low Grade Glioma 20%, Medulloblastoma/PNET 15%, Sarcoma 10%, Other 15%.
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, 33176
About this study
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.
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.
Read the 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
- Keywords
- brain, pediatrics brain cancer, pediatrics, skull
- Medical subject headings
- Brain Neoplasms, Skull Base Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
Measure temporal changes in morphometry
Measure temporal changes in morphometry after exposure to therapeutic RT and to correlate these changes with absorbed dose.
Measured: Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
Secondary outcomes (1)
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.
Measured: Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start8 Mar 2019
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Matthew D Hall, MD, Principal investigator, Miami Cancer Institute (MCI) at Baptist Health South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972514
- Sponsor's protocol ID
- 2018-LLB-HALL-001
- Status last verified
- Jul 2026
- First submitted
- 25 Apr 2019
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03972514
- Acronym / sponsor ID
- 2018-LLB-HALL-001
- Conditions
- Brain Tumor, Brain Cancer, Skull Base Tumor
- Keywords
- brain, pediatrics brain cancer, pediatrics, skull
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study sample size will be 60 patients. This sample size was selected to ensure an adequate distribution of primary tumor diagnoses and dosimetric variation in major brain substructures treated based on tumor location/brain regions treated. The estimated case distribution based on historical data from 2007-2015 will be: Craniopharyngioma 20%, Ependymoma 20%, Low Grade Glioma 20%, Medulloblastoma/PNET 15%, Sarcoma 10%, Other 15%.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure temporal changes in brain volumes
Time frame: Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
Measure temporal changes in brain volumes after exposure to therapeutic RT and to correlate these changes with absorbed dose.
Measure temporal changes in morphometry
Time frame: Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
Measure temporal changes in morphometry after exposure to therapeutic RT and to correlate these changes with absorbed dose.
1 secondary outcome
Morphometric changes in the brain
Time frame: Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Miami Cancer Institute WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew D Hall, MD principal investigator
Miami Cancer Institute (MCI) at Baptist Health South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Brain Cancer, run by Baptist Health South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure temporal changes in brain volumes (time frame: Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.