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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 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.

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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.

Conditions Studied

Interventions

  • DEVICE RS-fMRI

Study Locations (1)

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2020-09-02
Est. Completion 2033-10-31

What the Registry Record Tells You About NCT04975139

The ClinicalTrials.gov registry entry for NCT04975139 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (54% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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