Brain Tumor, PrimaryNCT06185686
Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
An observational study of Brain Tumor, Primary, run by Washington University School of Medicine at 1 site in United States.
Trial summary
With modern therapy, the survival rate for pediatric brain tumor patients has significantly improved, with over 70% of patients surviving their disease. However, this progress often comes at the cost of substantial morbidity, with cognitive deficits being the primary obstacle to independent living. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Brain Tumor, Primary
- What is being tested?
- Cognitive testing and Resting State MRI/Precision functional mapping
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2024to 31 Jul 2027
- 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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Treated at Siteman Cancer Center at Washington University School of Medicine.
Who may be able to join
- Between 8 and 21 years of age, inclusive
- Newly diagnosed primary brain tumor of any location and any histology that will be treated with proton radiation therapy
- Life expectancy of at least one year
- Able to understand and willing to consent or assent to the research proposed (or that of a legally authorized representative, if applicable), along with consent of legal guardian(s) if applicable
Who cannot join
- Presence of visual impairment to an extent that the patient is unable to complete the computer testing
- Contraindication to MRI scan (i.e. due to cardiac pacemaker)
- Presence of programmable shunt or dental braces
- Requires sedation for MRI scans
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine/Saint Louis Children's Hospital
St Louis, Missouri, 63110
Stephanie Perkins, M.D., 314-747-4405, sperkins@wustl.edu
Stephanie Perkins, M.D.
About this study
Official title: Assessing Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
With modern therapy, the survival rate for pediatric brain tumor patients has significantly improved, with over 70% of patients surviving their disease. However, this progress often comes at the cost of substantial morbidity, with cognitive deficits being the primary obstacle to independent living. Robust predictors of cognitive decline and a comprehensive understanding of the underlying mechanisms of cognitive injury remain elusive. This study will prospectively investigate alterations in brain resting state networks following radiation therapy using functional imaging. The hypothesis is that radiation therapy leads to dose-dependent alterations in functional connectivity in the networks associated with higher level cognition, ultimately leading to cognitive decline.
- Conditions
- Brain Tumor, Primary
- Being tested
- Cognitive testing, Resting State MRI/Precision functional mapping
- Keywords
- Proton therapy, Radiation, Brain tumor
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive testingOther
NIH Toolbox Cognitive Battery and the Novel Cognitive Measure (NCM)
Resting State MRI/Precision functional mappingDevice
Also called RSFC MRI
At baseline (before the end of radiation therapy) and approximately 12 months after the completion of radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Brain tumor patients receiving proton radiation therapy | Patients between 8 and 21 years old (inclusive) with a newly diagnosed primary brain tumor that will be treated with proton radiation therapy Receives: Other: Cognitive testing; Device: Resting State MRI/Precision functional mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation induced effects on functional brain resting state connectivity
The investigators will compare resting state maps of each patient pre- and post-radiation therapy. The investigators will evaluate changes in the resting state architecture and compare to the average results that would be expected from a patient in the same age and sex.
Measured: Through 1 year follow-up
Baseline characteristics of functional network architecture
The investigators will assess the unique architecture of brain networks at diagnosis and how significantly this architecture diverges from average healthy controls.
Measured: At baseline (day 1)
Change in characteristics of functional network architecture
The investigators will assess brain system segregation which is measure of the connection and disconnection between different brain networks. These will be compared within individuals and compared to healthy controls.
Measured: Baseline and 1 year follow-up
Secondary outcomes (1)
Correlation of radiation dose to changes in cognitive performance and resting state network connectivity
In an exploratory fashion, the investigators will evaluate the dose of radiation received to each resting state network to determine if functional connectivity changes in a dose dependent manner at 1 year.
Measured: At 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start10 Jul 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, PrimaryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, The Foundation for Barnes-Jewish Hospital, Children's Cancer Research Fund
- Responsible party
- Sponsor
- Investigators
- Stephanie Perkins, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185686
- Sponsor's protocol ID
- 202312104
- Status last verified
- Jul 2026
- First submitted
- 14 Dec 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT06185686
- Acronym / sponsor ID
- 202312104
- Conditions
- Brain Tumor, Primary
- Keywords
- Proton therapy, Radiation, Brain tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- United States Department of Defense, The Foundation for Barnes-Jewish Hospital, Children's Cancer Research Fund
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 29 Dec 2023 (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.
With modern therapy, the survival rate for pediatric brain tumor patients has significantly improved, with over 70% of patients surviving their disease. However, this progress often comes at the cost of substantial morbidity, with cognitive deficits being the primary obstacle to independent living. Robust predictors of cognitive decline and a comprehensive understanding of the underlying mechanisms of cognitive injury remain elusive. This study will prospectively investigate alterations in brain resting state networks following radiation therapy using functional imaging. The hypothesis is that radiation therapy leads to dose-dependent alterations in functional connectivity in the networks associated with higher level cognition, ultimately leading to cognitive decline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain tumor patients receiving proton radiation therapy | – | Other: Cognitive testing, Device: Resting State MRI/Precision functional mappingPatients between 8 and 21 years old (inclusive) with a newly diagnosed primary brain tumor that will be treated with proton radiation therapy |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Treated at Siteman Cancer Center at Washington University School of Medicine.
Key inclusion criteria (4 listed)
- Between 8 and 21 years of age, inclusive
- Newly diagnosed primary brain tumor of any location and any histology that will be treated with proton radiation therapy
- Life expectancy of at least one year
- Able to understand and willing to consent or assent to the research proposed (or that of a legally authorized representative, if applicable), along with consent of legal guardian(s) if applicable
Key exclusion criteria (4 listed)
- Presence of visual impairment to an extent that the patient is unable to complete the computer testing
- Contraindication to MRI scan (i.e. due to cardiac pacemaker)
- Presence of programmable shunt or dental braces
- Requires sedation for MRI scans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive testingNIH Toolbox Cognitive Battery and the Novel Cognitive Measure (NCM) | Other | Brain tumor patients receiving proton radiation therapy |
| Resting State MRI/Precision functional mappingAlso: RSFC MRIAt baseline (before the end of radiation therapy) and approximately 12 months after the completion of radiation therapy. | Device | Brain tumor patients receiving proton radiation therapy |
Primary outcome
Radiation induced effects on functional brain resting state connectivity
Time frame: Through 1 year follow-up
The investigators will compare resting state maps of each patient pre- and post-radiation therapy. The investigators will evaluate changes in the resting state architecture and compare to the average results that would be expected from a patient in the same age and sex.
Baseline characteristics of functional network architecture
Time frame: At baseline (day 1)
The investigators will assess the unique architecture of brain networks at diagnosis and how significantly this architecture diverges from average healthy controls.
Change in characteristics of functional network architecture
Time frame: Baseline and 1 year follow-up
The investigators will assess brain system segregation which is measure of the connection and disconnection between different brain networks. These will be compared within individuals and compared to healthy controls.
1 secondary outcome
Correlation of radiation dose to changes in cognitive performance and resting state network connectivity
Time frame: At 1 year follow-up
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 17 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Stephanie Perkins, M.D. principal investigator
Washington University School of Medicine
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, Primary, run by Washington University School of Medicine 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: looking for participants now, as of the sponsor's last update on 17 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?
Contact Stephanie Perkins, M.D. (314-747-4405, sperkins@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation induced effects on functional brain resting state connectivity (time frame: Through 1 year follow-up). The study lists 3 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 17 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.