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NCT05658731 · ClinicalTrials.gov registry record · NA
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
A NA study of Head and Neck Cancer and Brain Tumor, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- NA
- Development phase
- 338
- Enrollment target
- 2
- Study locations
NCT05658731: Recruiting NA study of Head and Neck Cancer and Brain Tumor, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT05658731 is a NA study of Head and Neck Cancer and Brain Tumor that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 338 participants, above the 259-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (31% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05658731, a NA study of Head and Neck Cancer and Brain Tumor, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- NA
- Development phase
- 338 participants
- Enrollment target
- 2
- Study locations
Study Summary
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. Survivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed. Healthy children will also be enrolled and have research MRIs done. The researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.
Primary Outcome
Number of plans that meet substructure-informed constraints (per protocol) divided by the total number of plans.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST MRI
- RADIATION substructure informed planning
- OTHER Neurocognitive Testing
Study Locations (2)
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2023-05-17 |
| Est. Completion | 2035-12 |
| Phase | NA |
What NCT05658731 shows while recruiting
NCT05658731 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, above the 259-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (31% higher).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which MRI is the first listed.
NCT05658731 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT05658731 about?
NCT05658731 is a clinical study titled "Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients". 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...
What is the current status of trial NCT05658731?
This trial is currently recruiting. It is a NA study. The enrollment target is 338 participants. The study started on 2023-05-17. Estimated completion is 2035-12.
What conditions does trial NCT05658731 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Brain Tumor.
What interventions are being tested in trial NCT05658731?
The interventions under investigation include: MRI (DIAGNOSTIC_TEST), substructure informed planning (RADIATION), Neurocognitive Testing (OTHER).
Who is sponsoring clinical trial NCT05658731?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05658731 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05658731's enrollment target sits among peer trials
338 30th of 250 higher than 221 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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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