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NCT04390906 · ClinicalTrials.gov registry record
A Study of Cognitive Changes in Patients Receiving Brain Radiation
A clinical trial of Brain Tumor Adult, sponsored by University of Rochester.
- Active
- Registry status
- 75
- Enrollment target
- 1
- Study location
NCT04390906: Active study of Brain Tumor Adult, sponsored by University of Rochester.
NCT04390906 is a study of Brain Tumor Adult that is active but no longer recruiting, run by University of Rochester. The registered enrollment target is 75 participants, above the 67-participant average among 6 other Brain Tumor Adult trials with a reported enrollment target (12% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04390906, a study of Brain Tumor Adult, is active but no longer recruiting, sponsored by University of Rochester.
- ACTIVE NOT RECRUITING
- Registry status
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
Cranial radiation therapy (RT), commonly used to treat benign and malignant brain tumors, can lead to cognitive impairments in domains not related to neuroanatomic structures directly impacted by the tumor. The study will prospectively enroll 75 patients with benign and low-grade brain tumors who will undergo partial brain RT, with either conventionally fractionated or hypofractionated schedules. Subjects will receive MRI scans at baseline, 6 months, and 12 months. Given the role of the limbic system in key cognitive functions affected by RT, researchers have a particular interest in characterizing MRI changes in the limbic system and thalamus in relation to memory and related processes. Specific Aims: 1. To examine objective neurocognitive changes over time. The investigators hypothesize that they will see RT-induced neurocognitive impairment in up to 50% of patients after cranial RT. 2. To examine changes in brain tissue (via MRI) induced by off-target RT in patients with benign and low-grade brain tumors. The investigators specifically hypothesize that comapping of RT dose and MRI changes in the thalamus and limbic system (i.e., thalamic nuclei, hippocampus, fornix, hypothalamus/mammillary bodies, limbic lobe, cingulum) will be most distorted by off-target RT. 3. To examine the relationship between MRI changes for key neuroanatomic structures identified in Aim 1 with objective neurocognitive testing. The investigators hypothesize that cognitive decline will be correlated with damage revealed by MRI to limbic and thalamic structures. This research will help to define which neuroanatomic structures are most at risk from RT-induced damage and will help ultimately establish new dose constraint guidelines for important structures to improve cognitive outcomes.
Primary Outcome
Serial neurocognitive testing using raw scores from the HVLT-R delayed recall
Conditions Studied
Study Locations (1)
New York
- James P. Wilmot Cancer Center at University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2027-01-01 |
What the registry record for NCT04390906 still lists
NCT04390906 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 67-participant average among 6 other Brain Tumor Adult trials with a reported enrollment target (12% higher).
The record links to 1 condition, with Brain Tumor Adult appearing as the primary indexed condition, and to 0 interventions.
NCT04390906 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04390906 about?
NCT04390906 is a clinical study titled "A Study of Cognitive Changes in Patients Receiving Brain Radiation". Cranial radiation therapy (RT), commonly used to treat benign and malignant brain tumors, can lead to cognitive impairments in domains not related to neuroanatomic structures directly impacted by the tumor. The study will prospectively enroll 75 patients with benign and low-grade brain tumors who wi...
What is the current status of trial NCT04390906?
This trial is currently active not recruiting. The enrollment target is 75 participants. The study started on 2018-10-16. Estimated completion is 2027-01-01.
What conditions does trial NCT04390906 study?
This clinical trial studies the following conditions: Brain Tumor Adult.
Who is sponsoring clinical trial NCT04390906?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04390906 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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