Brain Tumor study: Neurocognitive Testing vs MRI
Official title Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
ClinicalTrials.gov ID: NCT05658731
What this study is testing
- What it's testing
- The study wants to see whether giving less radiation to parts of the brain that help thinking and learning can lower cognitive problems after treatment.
- Who it's for
- Children newly diagnosed with brain or head‑and‑neck tumors who will receive radiation, survivors who finished radiation at least two years ago, and healthy children.
- What's involved
- Participants will have neurocognitive tests and MRI scans. The radiation plan will be examined to see how much dose different brain areas received, and brain changes will be compared across groups.
- Time commitment
- The study lasts until the final MRI and test, with visits for testing and imaging scheduled during and after radiation treatment or at follow‑up times.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 26. Healthy volunteers may be eligible.
You may be able to join if
- STRATUM A
- Eligibility Criteria
- aged 1 to \<26 years of age
- tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit
- treatment must include radiation therapy (either proton or photon)
You likely can't join if
- pregnancy
- patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid...
- STRATUM B
- Eligibility Criteria
- diagnosed with a brain tumor at \<26 years of age
- received radiation to the brain as part of therapy
See the full eligibility criteria
- STRATUM A
- Eligibility Criteria
- aged 1 to \<26 years of age
- tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit
- treatment must include radiation therapy (either proton or photon)
- patients must not have completed radiation therapy
- pregnancy
- patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
- STRATUM B
- Eligibility Criteria
- diagnosed with a brain tumor at \<26 years of age
- received radiation to the brain as part of therapy
- time from radiation start to study enrollment is ≥ 2 years
- there has not been disease recurrence from time of most recent radiation treatment to study enrollment
- Exclusion Criteria
- patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
- STRATUM C
- Eligibility Criteria
- must be aged 5 to \<26 years of age
- must be able to complete research imaging without sedation
- Exclusion Criteria
- must not have any major psychiatric, neurologic or medical diagnosis
The study team makes the final eligibility decision.
Where it is enrolling
- Washington D.C., District of Columbia, United States
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 26 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.