Patient Satisfaction, Diagnostic AccuracyNCT02726594
Evaluation of Patient Comfort and Image Quality in Magnetic Resonance Imaging
An observational study of Patient Satisfaction, Diagnostic Accuracy, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Diagnostic Accuracy
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2015to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Overall, 1,000 participants will be included in the study, consisting of healthy volunteers (N = 300) as well as patients (N = 700).
Who may be able to join
- acceptance of study participation
- age ≥ 18 years.
Who cannot join
- General established contraindications for MRI (i.e. pacemaker implantation with non-compatible pacemakers and pacemaker leads, implantation of other non-MRI-compatible medical devices, metal parts in the body, etc.)
- A pregnancy constitutes an exclusion criterion. If there could be a potentially pregnancy, a pregnancy test will be performed
- claustrophobia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich
Gustav Andreisek, PD Dr. med., +41 44 255 11, gustav.andreisek@usz.ch
About this study
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 patient's perception/comfort 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.
Read the 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 patient's 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 patient's perception/comfort 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.
- Keywords
- Magnetic Resonance Imaging, Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | For the present study, patients who are assigned to the clinically indicated MRI scan, as well as healthy subjects will be included. Healthy volunteers will be recruited through public notices (flyer) (mainly in the district of the University Zurich / USZ). For all patients, the duration of clinical MRI routine examination is 30-90 minutes, depending on the requirements to answer the clinical question. The subjects are interviewed after the MRI scan by a visual analog scale oral and written on various aspects of their perception during the examination. This means an additional expenditure of time of about 10 minutes. The patients arises except for this additional time not a disadvantage by taking part in the study. | |
| Subjects | For the present study, patients who are assigned to the clinically indicated MRI scan, as well as healthy subjects will be included. Healthy volunteers will be recruited through public notices (flyer) (mainly in the district ETH / USZ). For all patients, the duration of clinical MRI routine examination is 30-90 minutes, depending on the requirements to answer the clinical question. The subjects are interviewed after the MRI scan by a visual analog scale oral and written on various aspects of their perception during the examination. This means an additional expenditure of time of about 10 minutes. The patients arises except for this additional time not a disadvantage by taking part in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort
by questionnaires
Measured: procedure
Secondary outcomes (1)
Image quality
by analysis of MRI images
Measured: procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startAug 2015
- Primary completionJun 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Satisfaction, Diagnostic AccuracyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustav Andreisek, University of Zurich
- Investigators
- Gustav Andreisek, PD Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726594
- Sponsor's protocol ID
- KEK-ZH-Nr. 2015-0081
- Status last verified
- Apr 2016
- First submitted
- 29 Mar 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Comfort and Image Quality in Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02726594
- Acronym / sponsor ID
- KEK-ZH-Nr. 2015-0081
- Keywords
- Magnetic Resonance Imaging, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patient's perception/comfort 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 patient's 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 patient's perception/comfort 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –For the present study, patients who are assigned to the clinically indicated MRI scan, as well as healthy subjects will be included. Healthy volunteers will be recruited through public notices (flyer) (mainly in the district of the University Zurich / USZ). For all patients, the duration of clinical MRI routine examination is 30-90 minutes, depending on the requirements to answer the clinical question. The subjects are interviewed after the MRI scan by a visual analog scale oral and written on various aspects of their perception during the examination. This means an additional expenditure of time of about 10 minutes. The patients arises except for this additional time not a disadvantage by taking part in the study. |
| Subjects | – | –For the present study, patients who are assigned to the clinically indicated MRI scan, as well as healthy subjects will be included. Healthy volunteers will be recruited through public notices (flyer) (mainly in the district ETH / USZ). For all patients, the duration of clinical MRI routine examination is 30-90 minutes, depending on the requirements to answer the clinical question. The subjects are interviewed after the MRI scan by a visual analog scale oral and written on various aspects of their perception during the examination. This means an additional expenditure of time of about 10 minutes. The patients arises except for this additional time not a disadvantage by taking part in the study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Overall, 1,000 participants will be included in the study, consisting of healthy volunteers (N = 300) as well as patients (N = 700).
Key inclusion criteria (2 listed)
- acceptance of study participation
- age ≥ 18 years.
Key exclusion criteria (3 listed)
- General established contraindications for MRI (i.e. pacemaker implantation with non-compatible pacemakers and pacemaker leads, implantation of other non-MRI-compatible medical devices, metal parts in the body, etc.)
- A pregnancy constitutes an exclusion criterion. If there could be a potentially pregnancy, a pregnancy test will be performed
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient comfort
Time frame: procedure
by questionnaires
1 secondary outcome
Image quality
Time frame: procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav Andreisek, PD Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction, Diagnostic Accuracy, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gustav Andreisek, PD Dr. med. (+41 44 255 11, gustav.andreisek@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comfort (time frame: procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.