BridgeMD
New treatment option for Brain Tumor
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 goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients. Patients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study.
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's taking place
- 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 - 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?
Study sites include Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.