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NCT05288439 · ClinicalTrials.gov registry record · NA
A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor
A NA study of Brain Tumor and Metastatic Brain Tumor, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05288439: Active NA study of Brain Tumor and Metastatic Brain Tumor, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05288439 is a NA study of Brain Tumor and Metastatic Brain Tumor that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 30 participants, below the 281-participant average among 69 other Brain Tumor trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05288439, a NA study of Brain Tumor and Metastatic Brain Tumor, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The researchers are doing this study to find out if there are differences in the resting state brain networks of children and young adults (ages 6-25) after treatment with proton beam radiation therapy (PBRT). The researchers will use resting state functional connectivity magnetic resonance imagining (rs-fcMRI) scanning to detect these differences. The researchers will also check for differences in participants' thinking and quality of life through a cognitive assessment and a questionnaire. Both people undergoing PBRT for a brain tumor and healthy people will take part in this study so that the researchers can compare the brain networks (connections in the brain that are involved in certain function, such as memory or attention), thinking patterns, and quality of life of these two groups of participants. The study researchers think that rs-fcMRI scans may be an effective way to look at the brain networks after treatment with PBRT and see if this treatment causes differences in those networks, including damage to the brain (neurotoxicity). rs-fcMRI scans take images when a patient is in a resting state, which means the patient is not performing a task or thinking about anything in particular. This study will provide valuable information about how PBRT affects brain networks, thinking (cognitive) abilities, and quality of life in children and young adults. The study results may have an impact on future treatment approaches for brain cancer and the use of PBRT in children and young adults.
Primary Outcome
A single rs-fcMRI sequence will be added to the MRI performed as standard of care follow-up 3-5 months after completion of cranial PBRT in pediatric patients treated for brain tumors to assess for early post-PBRT network disruption. Using resting state functional connectivity magnetic resonance imagining (rs-fcMRI) scanning to detect these differences.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Resting-state functional connectivity MRI
- OTHER Neurocognitive battery with quality-of-life assessment
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2027-03 |
| Phase | NA |
What the registry record for NCT05288439 still lists
NCT05288439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 281-participant average among 69 other Brain Tumor trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Brain Tumor appearing as the primary indexed condition, and to 2 interventions - of which Resting-state functional connectivity MRI is the first listed.
NCT05288439 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05288439 about?
NCT05288439 is a clinical study titled "A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor". The researchers are doing this study to find out if there are differences in the resting state brain networks of children and young adults (ages 6-25) after treatment with proton beam radiation therapy (PBRT). The researchers will use resting state functional connectivity magnetic resonance imaginin...
What is the current status of trial NCT05288439?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2022-03-07. Estimated completion is 2027-03.
What conditions does trial NCT05288439 study?
This clinical trial studies the following conditions: Brain Tumor, Metastatic Brain Tumor.
What interventions are being tested in trial NCT05288439?
The interventions under investigation include: Resting-state functional connectivity MRI (DIAGNOSTIC_TEST), Neurocognitive battery with quality-of-life assessment (OTHER).
Who is sponsoring clinical trial NCT05288439?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05288439 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05288439's enrollment target sits among peer trials
30 46th of 69 higher than 20 of 69 other Brain Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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