Development of Protocols and Methods for Image Processing and Enhancement of MRI Data

NCT04861532 | Unknown

• 1 other identifier: 0106-16-HYMC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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". 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

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.

• 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.

• 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.

• 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

Imaging DIAGNOSTIC_TEST

MRI scanning using new protocols

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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. 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.

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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead
• Medic Vision Imaging Solutions: collaborator

Study Sites (1)

Hillel Yaffe

Hadera, Select One, OTHER, Israel

RECRUITING

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Libi Mori

  Medic Vision Imaging Solutions Ltd

  STUDY DIRECTOR

• Roni Shreter

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Libi Mori

CONTACT

+972.73.726.2226; LIBI@MEDICVISION.COM

Study Design

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

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 27, 2021
• Study Start: April 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 30, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-04

Locations

IL (1)