Feasibility Testing of 7-Tesla Magnetic Resonance Imaging

Magnetic Resonance Imaging Clinical Trial

Official title:

Explorative Technical Feasibility Testing of 7-Tesla Magnetic Resonance Imaging of the Musculoskeletal System and of the Head

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992298
• Other study ID #: I0171
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: August 2023
• Source: Balgrist University Hospital
• Contact: Reto Sutter, Prof.
• Phone: +41 44 386 33 08
• Email: reto.sutter[@]balgrist.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

Other:
• 7 T MRI vs 3 T MRI
Adult healthy and patient volunteers will undergo a ca. 1 hour examination of non-invasive magnetic-resonance imaging at 7T, and, if appropriate, a closely matching examination at 3T as a standard of reference.

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Reto Sutter, MD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative image quality of 7 T MRI	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.	through study completion, an average of 1 year