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NCT04975139 · ClinicalTrials.gov registry record
Cognitive Changes of IDH-mutant and IDH-wildtype Glioma Patients After Chemoradiotherapy With Radiation Dose to the Resting State Networks
A clinical trial of Glioma, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- 96
- Enrollment target
- 1
- Study location
NCT04975139: Recruiting study of Glioma, sponsored by Washington University School of Medicine.
NCT04975139 is a study of Glioma that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 96 participants, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04975139, a study of Glioma, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- 96 participants
- Enrollment target
- 1
- Study location
Study Summary
Neurocognitive decline after radiation therapy is one of the most concerning complication for brain tumor patients and neuro-oncologists. There are increasing technological advances in evaluating the brain's neural connections responsible for the neurocognitive processes. For example, resting-state functional MRI (RS-fMRI) is an advanced imaging method that can identify the spatiotemporal distribution of the intrinsic functional networks within the brain (also referred to as resting state networks (RSNs) without requiring specific tasks by the imaged participants. Although there is evidence that shows that avoidance of specific neural networks during radiation therapy planning can lead to improved preservation of neurocognitive function afterward, it is important to first identify the most vulnerable and clinically relevant RSNs that correspond to cognitive decline. In this study, the investigators will prospectively perform RS-fMRI and neurocognitive evaluation using the NIH Toolbox Cognitive Battery (NIHTB-CB) on patients with gliomas before and after radiation therapy to generate preliminary data on what RSNs are most vulnerable to radiation injury leading to cognitive decline. A benign brain tumor cohort will also be followed to serve as control. The investigators will also evaluate the feasibility of incorporating RS-fMRI with radiation planning software for treatment optimization.
Primary Outcome
-The National Institutes of Health (NIH) has developed the National Institutes of Health Toolbox for the Assessment of Neurological and Behavior Function (NIHTB), which is a validated, normed, and multidimensional set of brief measures to assess cognitive, emotional, motor, and sensory function. The NIHTB cognitive battery (NIHTB-CB) consists of 10 tasks and can be administered in 40 min. The scores can be evaluated separately, or they can be combined into composite scores: crystallized cognitio
Conditions Studied
Interventions
- DEVICE RS-fMRI
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2020-09-02 |
| Est. Completion | 2033-10-31 |
What NCT04975139 shows while recruiting
NCT04975139 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which RS-fMRI is the first listed.
NCT04975139 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04975139 about?
NCT04975139 is a clinical study titled "Cognitive Changes of IDH-mutant and IDH-wildtype Glioma Patients After Chemoradiotherapy With Radiation Dose to the Resting State Networks". Neurocognitive decline after radiation therapy is one of the most concerning complication for brain tumor patients and neuro-oncologists. There are increasing technological advances in evaluating the brain's neural connections responsible for the neurocognitive processes. For example, resting-state ...
What is the current status of trial NCT04975139?
This trial is currently recruiting. The enrollment target is 96 participants. The study started on 2020-09-02. Estimated completion is 2033-10-31.
What conditions does trial NCT04975139 study?
This clinical trial studies the following conditions: Glioma.
What interventions are being tested in trial NCT04975139?
The interventions under investigation include: RS-fMRI (DEVICE).
Who is sponsoring clinical trial NCT04975139?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04975139 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04975139's enrollment target sits among peer trials
96 23rd of 87 higher than 65 of 87 other Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioma 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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