- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04861532
Development of Protocols and Methods for Image Processing and Enhancement of MRI Data
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Libi Mori
- Phone Number: +972.73.726.2226
- Email: LIBI@MEDICVISION.COM
Study Locations
-
-
Select One
-
Hadera, Select One, Israel, OTHER
- Recruiting
- Hillel Yaffe
-
Contact:
- Libi Mori
- Email: LIBI@MEDICVISION.COM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Total number of subjects expected to participate in this study is up to 100. This study will be performed at multiple sites and data will be collected from different MRI scanners of variable field strength using several MRI protocols. To provide sufficient statistical power for the investigation of each subgroup, we need a large sample size.
Children, pregnant women and prisoners that are considered vulnerable population by federal regulation will not be included in this study. In addition, decisional incapacity subject will be excluded.
Description
Inclusion Criteria:
- Volunteers for clinical MRI examination
- Patients undergoing clinical MRI examination
- Capable to provide an informed written consent form
Exclusion Criteria:
- Any contraindication to MRI scanning, such as pacemakers or heart rhythm disturbances, permanent cosmetics or certain metallic implants in the body (excluding dental implants).
- Age <18 years old
- Pregnancy
- Claustrophobia
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Image Signal to Noise Ratio (SNR)
Time Frame: Through study completion, an average of 2 months.
|
Comparing the SNR of images obtained by conventional protocols with the corresponding New Protocols' processed images.
The comparison will be performed by neuroradiologists, using a 7-point Likert-scale.
Where higher the score, better the outcome (1 means unacceptable and 7 means excellent).
|
Through study completion, an average of 2 months.
|
Image Resolution
Time Frame: Through study completion, an average of 2 months.
|
Comparing the resolution of images obtained by conventional protocols with the corresponding New Protocols' processed images.
The comparison will be performed by neuroradiologists, using a 7-point Likert-scale.
Where higher the score, better the outcome (1 means unacceptable and 7 means excellent).
|
Through study completion, an average of 2 months.
|
MRI contrast
Time Frame: Through study completion, an average of 2 months.
|
Comparing MR contrast of images obtained by conventional protocols with the corresponding New Protocols' processed images.
The comparison will be performed by neuroradiologists, using a 7-point Likert-scale.
Where higher the score, better the outcome (1 means unacceptable and 7 means excellent).
|
Through study completion, an average of 2 months.
|
Artifacts
Time Frame: Through study completion, an average of 2 months.
|
Comparing artifacts of images obtained by conventional protocols with the corresponding New Protocols' processed images.
The comparison will be performed by neuroradiologists, using a 7-point Likert-scale.
Where higher the score, better the outcome (1 means unacceptable and 7 means excellent).
|
Through study completion, an average of 2 months.
|
Diagnostic quality
Time Frame: Through study completion, an average of 2 months.
|
Comparing diagnostic quality of images obtained by conventional protocols with the corresponding New Protocols' processed images.
The comparison will be performed by neuroradiologists, using a 7-point Likert-scale.
Where higher the score, better the outcome (1 means unacceptable and 7 means excellent).
|
Through study completion, an average of 2 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Libi Mori, Medic Vision Imaging Solutions Ltd
- Principal Investigator: Roni Shreter, Hillel Yaffe Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0106-16-HYMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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