Feasibility Testing of 7-Tesla Magnetic Resonance Imaging

Not Applicable

Recruiting

• Conditions: Magnetic Resonance Imaging
• Interventions: Other: 7 T MRI vs 3 T MRI

• Registration Number: NCT05992298
• Lead Sponsor: Reto Sutter, MD

Brief Summary

The goal of the current project is to explore and develop the technical feasibility of non-invasive imaging of the human musculoskeletal system and head with the first 7T MR scanner with a CE mark to identify areas where the higher field promises significant benefits in qualitative image quality. For a subset of the planned exams, state-of-the art 7T or 3T images will be used as standard of reference to comparatively gauge the qualitative image quality of the investigational 7T images.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-18
• Study Start: 2023-08-07
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2028-02-29
• Study Completion: 2028-02-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• Consent to undergo a 7T (and, if appropriate a comparative 3T) MRI exam.
• For some of the consistent small series: presence of a specific condition of the musculoskeletal system or of the head. This can include traumatic or degenerative changes, e.g., of tendons, cartilage, muscle, peripheral nerves, ligaments, and bones, or in the brain, as well as focal lesions, e.g., tumors.

Exclusion Criteria

• Contraindications to undergo a MRI examination at a field strength of 7 Tesla or at 3 Tesla.
• Irregular anatomy and/or tissue properties
• Inability to consent - for any reason.
• Body mass above 200 kg.
• Body mass below 30 kg.
• Women: pregnancy.
• Age below 18.
• Known or suspected non-compliance, drug or alcohol abuse.
• Inability to follow the procedures of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
7 T MRI	7 T MRI vs 3 T MRI	-

Primary Outcome Measures

Name	Time	Method
Qualitative image quality of 7 T MRI	through study completion, an average of 1 year	Current-day feasibility of various types of MR examinations of the human musculoskeletal system. The primary outcomes of small consistent series of the study are visual gradings and qualitative measures of image quality. Image quality is rated by independent readers using Likert scales.

Trial Locations

Locations (1)

Balgrist University Hospital; 🇨🇭 Zurich, Switzerland