Feasibility Testing of 7-Tesla Magnetic Resonance Imaging
ConditionMagnetic Resonance Imaging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorReto Sutter, MD
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
7 T MRI vs 3 T MRI
Other interventionAdult 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.
Treatment groups
780 Participants
are divided into 1 treatment groupGroup A: 7 T MRIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Reto Sutter, MD
Lead sponsor
Balgrist University Hospital
Sponsor institution
Source ClinicalTrials.gov