Development of Protocols and Methods for Image Processing and Enhancement of Magnetic Resonance Imaging (MRI) Data.

April 4, 2022 updated by: Medic Vision Imaging Solutions Ltd

The purpose of the study is to develop new methods for image processing and enhancement of MRI data. Different setting of acquisition parameters used in conventional clinical MRI protocols will be defined, to create "New Protocols".

The specific aim of this study is to assess and to improve the performance of our image processing methods, by comparing diagnostic qualities of images obtained by conventional MRI protocols with those obtained by corresponding New Protocols' and processed by our image enhancement method.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Total number of subjects expected to participate in this study is up to 100. The study population consists of patients who will go through their standard care MRI exam. 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
  • Decisional incapacity, mentally disabled,
  • MRI exam under sedation or monitoring equipment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • iQMR_CSP_01-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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