Ignite Creation Date:
2024-05-06 @ 8:24 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02726594
Status:
UNKNOWN
Last Update Posted:
2016-04-05
First Post:
2016-03-29
Brief Title:
Evaluation of Patient Comfort and Image Quality in Magnetic Resonance Imaging
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Evaluation of Patient Comfort and Image Quality in Magnetic Resonance Imaging
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this prospective monocentric study is to evaluate the patient comfort in MRI and to measure examination conditions and factors that may affect the image quality and thus the diagnostic accuracy For this purpose a total of 1000 participants enrolled in the study consisting of healthy volunteers N 300 as well as patients N 700 that are assigned to the clinically indicated MRI scan In this study individual regions of the body are studied by MRI for example knee ankle head or spine For all participants of the study the investigation for each region examined is exactly the same except that a single external factor is changed or is different Such variable factors may include the tube diameter of the magnet weight of the coil which is closely attached to the examined area of the body the height adjustment of the table on which the participants lie the duration of the study protocol and the generated volume during the investigation Participants are involuntarily subjected to the particular MRI scanner and setting by availability of USZ Radiology disposition For the evaluation of the data participants will be matched in terms of the body regions being examined and based on being part of the patient or subject group Due to the fine different experimental conditions the influence of these factors on study patient comfort as wells as the image quality and thus the diagnostic accuracy will investigated By this approach the relevant factors will be examined in isolation Only by exploring the patients perceptioncomfort during an MRI scan the patient-orientated design of the study conditions can be improved and thus the possibilities of modern MRI technology can be fully utilized in clinical practice
Detailed Description:
Background Magnetic resonance imaging MRI is an integral part of medical diagnostics since 20 years Using MRI soft tissue imaging of body regions such as the brain abdominal or musculoskeletal is possible and is clearly superior to other imaging techniques Due to the complex physical conditions a typical MRI scan will take 30-90 minutes during which the patient should not do any movements generates a noise level of 75-100 decibels and requires the placement of the patient in an often as cramped perceived tube scanner These adverse conditions are not only known to have a significantly negative impact on the patients comfort but can also change the image quality and thus reduce the diagnostic accuracy of an investigation
Motivation At the University Hospital Zurich USZ a total of 10 partly very different MR scanners are available for clinical imaging These devices differ by the manufacturer and by the different design of the premises the equipment the coil and the table sizes the logs up to the generated in the examination volume and the room temperature For example one of the existing examination rooms at the USZ has been equipped by a manufacturer with a costly patient comfort package This room serves as a showroom and as a positive example for maximum patient comfort Our experience shows that overall all the MRI scans of all units and the resulting image quality fluctuates greatly and the Patient Feedback for the individual studies is partly quite negative Improved study conditions are therefore accessible both in terms of patient comfort and improved diagnostic accuracy our goal
Current status of research The working group Research in Musculoskeletal Radiology at the Institute for Diagnostic and Interventional Radiology at the University Hospital Zurich is led by PhD Dr med Gustav Andreisek and under his authority already carried out successfully numerous projects in the field of magnetic resonance imaging
Objectives The aim of this prospective monocentric study is to evaluate the patient comfort in MRI and to measure examination conditions and factors that may affect the image quality and thus the diagnostic accuracy For this purpose a total of 1000 participants enrolled in the study consisting of healthy volunteers N 300 as well as patients N 700 which are assigned to the clinically indicated MRI scan In this study individual regions of the body are studied by MRI for example knee ankle head or spine For all participants in the study the investigation for each region examined is exactly the same except that a single external factor is changed or is different Such variable factors may include the tube diameter of the magnet weight of the coil which is closely attached to the examined area of the body the height adjustment of the table on which the participants lie the duration of the study protocol and the generated volume during the investigation Participants are involuntarily subjected to the particular MRI scanner and setting by availability of USZ Radiology disposition For the evaluation of the data participants will be matched in terms of the body regions being examined and based on being part of the patient or subject group Due to the fine different experimental conditions the influence of these factors on study patient comfort as wells as the image quality and thus the diagnostic accuracy will investigated By this approach the relevant factors will be examined in isolation Only by exploring the patients perceptioncomfort during an MRI scan the patient-orientated design of the study conditions can be improved and thus the possibilities of modern MRI technology can be fully utilized in clinical practice
Motivation At the University Hospital Zurich USZ a total of 10 partly very different MR scanners are available for clinical imaging These devices differ by the manufacturer and by the different design of the premises the equipment the coil and the table sizes the logs up to the generated in the examination volume and the room temperature For example one of the existing examination rooms at the USZ has been equipped by a manufacturer with a costly patient comfort package This room serves as a showroom and as a positive example for maximum patient comfort Our experience shows that overall all the MRI scans of all units and the resulting image quality fluctuates greatly and the Patient Feedback for the individual studies is partly quite negative Improved study conditions are therefore accessible both in terms of patient comfort and improved diagnostic accuracy our goal
Current status of research The working group Research in Musculoskeletal Radiology at the Institute for Diagnostic and Interventional Radiology at the University Hospital Zurich is led by PhD Dr med Gustav Andreisek and under his authority already carried out successfully numerous projects in the field of magnetic resonance imaging
Objectives The aim of this prospective monocentric study is to evaluate the patient comfort in MRI and to measure examination conditions and factors that may affect the image quality and thus the diagnostic accuracy For this purpose a total of 1000 participants enrolled in the study consisting of healthy volunteers N 300 as well as patients N 700 which are assigned to the clinically indicated MRI scan In this study individual regions of the body are studied by MRI for example knee ankle head or spine For all participants in the study the investigation for each region examined is exactly the same except that a single external factor is changed or is different Such variable factors may include the tube diameter of the magnet weight of the coil which is closely attached to the examined area of the body the height adjustment of the table on which the participants lie the duration of the study protocol and the generated volume during the investigation Participants are involuntarily subjected to the particular MRI scanner and setting by availability of USZ Radiology disposition For the evaluation of the data participants will be matched in terms of the body regions being examined and based on being part of the patient or subject group Due to the fine different experimental conditions the influence of these factors on study patient comfort as wells as the image quality and thus the diagnostic accuracy will investigated By this approach the relevant factors will be examined in isolation Only by exploring the patients perceptioncomfort during an MRI scan the patient-orientated design of the study conditions can be improved and thus the possibilities of modern MRI technology can be fully utilized in clinical practice
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