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

NCT04942704 | Unknown

• 1 other identifier: iQMR_CSP_01-00
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MRI Image Enhancement

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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).

  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).

  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).

  Through study completion, an average of 2 months.

Interventions

Non interventional Imaging - MRI OTHER

MRI Scanning using short protocols

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Volunteers for clinical MRI examination
• Patients undergoing clinical MRI examination
• Capable to provide an informed written consent form

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medic Vision Imaging Solutions Ltd: lead

Study Sites (1)

Houston Medical Imaging

Houston, Texas, 77098, United States

RECRUITING

Central Study Contacts

Libi Mori

CONTACT

+972522260167; libi@medicvision.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 28, 2021
• Study Start: June 15, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 30, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)