Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02218216
Status:
TERMINATED
Last Update Posted:
2017-07-24
First Post:
2014-08-13
Brief Title:
TBI MR Study 3 Houston Methodist
Sponsor:
GE Healthcare
Organization:
GE Healthcare
Study Overview
Official Title:
Advanced MRI Applications for Mild Traumatic Brain Injury - Study 3
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor terminated study early to start a larger feasability study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This hypothesis-generating feasibility study to determine potential associations between a broad range of clinical neurological symptoms and Magnetic Resonance Image MRI data and clinical findings involved in mild traumatic brain injury mTBI These associations will be examined over the acute and sub-acute period baseline to 3 months following injury to provide information useful for optimization of MR pulse sequences for mTBI applications
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment engineering development published research databases or registries mTBI data and images and other purposes determined by the Sponsor The results of this study are not intended for use in regulatory submissions
Subjects will be examined on commercially available MR scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by Sponsor
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment engineering development published research databases or registries mTBI data and images and other purposes determined by the Sponsor The results of this study are not intended for use in regulatory submissions
Subjects will be examined on commercially available MR scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by Sponsor
Detailed Description:
This hypothesis-generating feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and MR images data and clinical findings involved in mild traumatic brain injury mTBI These associations will be examined over the acute and sub-acute period approximately 3 months following injury to provide information useful for optimization of MR pulse sequences for mTBI applications
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment engineering development published research databases or registries mTBI data and images and other purposes determined by the Sponsor The results of this study are not intended for use in regulatory submissions
Subjects will be examined on commercially available MR scanners using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by GEHC
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment engineering development published research databases or registries mTBI data and images and other purposes determined by the Sponsor The results of this study are not intended for use in regulatory submissions
Subjects will be examined on commercially available MR scanners using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by GEHC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None