MRI Image EnhancementNCT04861532
Development of Protocols and Methods for Image Processing and Enhancement of MRI Data
An observational study of MRI Image Enhancement, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The purpose of the study is to develop new Magnetic Resonance Imaging (MRI) protocols and methods for image processing and enhancement. Different setting of acquisition parameters used in conventional clinical MRI protocols will be defined, to create "New Protocols". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MRI Image Enhancement
- What is being tested?
- Imaging
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2021to 30 Dec 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Volunteers for clinical MRI examination
- Patients undergoing clinical MRI examination
- Capable to provide an informed written consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe
Hadera, Select One, OTHER
Libi Mori, LIBI@MEDICVISION.COM
About this study
The purpose of the study is to develop new Magnetic Resonance Imaging (MRI) protocols and methods for image processing and enhancement. Different setting of acquisition parameters used in conventional clinical MRI protocols will be defined, to create "New Protocols". Then post-processing will be applied on new protocols to enhance the image quality. Finally a comparison of image quality will be performed to compare the image quality of images obtained by conventional protocols with those obtained with the New Protocols.
- Conditions
- MRI Image Enhancement
- Being tested
- Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDiagnostic test
MRI scanning using new protocols
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Signal to Noise Ratio (SNR)
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).
Measured: Through study completion, an average of 2 months.
Image Resolution
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).
Measured: Through study completion, an average of 2 months.
Artifacts
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).
Measured: Through study completion, an average of 2 months.
MRI contrast
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).
Measured: Through study completion, an average of 2 months.
Diagnostic quality
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).
Measured: Through study completion, an average of 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRI Image EnhancementStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- Medic Vision Imaging Solutions
- Responsible party
- Sponsor
- Investigators
- Libi Mori, Study director, Medic Vision Imaging Solutions LtdRoni Shreter, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861532
- Sponsor's protocol ID
- 0106-16-HYMC
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Protocols and Methods for Image Processing and Enhancement of MRI Data
- ClinicalTrials.gov ID
- NCT04861532
- Acronym / sponsor ID
- 0106-16-HYMC
- Conditions
- MRI Image Enhancement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- Medic Vision Imaging Solutions
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 27 Apr 2021 (actual)
- 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 purpose of the study is to develop new Magnetic Resonance Imaging (MRI) protocols and methods for image processing and enhancement. Different setting of acquisition parameters used in conventional clinical MRI protocols will be defined, to create "New Protocols". Then post-processing will be applied on new protocols to enhance the image quality. Finally a comparison of image quality will be performed to compare the image quality of images obtained by conventional protocols with those obtained with the New Protocols.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Volunteers for clinical MRI examination
- Patients undergoing clinical MRI examination
- Capable to provide an informed written consent form
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImagingMRI scanning using new protocols | Diagnostic test | – |
Primary outcome
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).
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Libi Mori study director
Medic Vision Imaging Solutions Ltd
Roni Shreter principal investigator
Hillel Yaffe Medical Center
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 MRI Image Enhancement, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 3 inclusion and 4 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 10 Jun 2021. 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 Israel. 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 Libi Mori (+972.73.726.2226, LIBI@MEDICVISION.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Signal to Noise Ratio (SNR) (time frame: Through study completion, an average of 2 months.). The study lists 5 primary outcomes in all. 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 10 Jun 2021.