Feasibility Testing of 7-Tesla Magnetic Resonance Imaging
Explorative Technical Feasibility Testing of 7-Tesla Magnetic Resonance Imaging of the Musculoskeletal System and of the Head
1 other identifier
interventional
780
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2023
CompletedStudy Start
First participant enrolled
August 7, 2023
CompletedFirst Posted
Study publicly available on registry
August 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 29, 2028
October 2, 2025
October 1, 2025
4.6 years
July 18, 2023
October 1, 2025
Conditions
Outcome Measures
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.
through study completion, an average of 1 year
Study Arms (1)
7 T MRI
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Reto Sutter, MDlead
Study Sites (1)
Balgrist University Hospital
Zurich, Canton of Zurich, 8008, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Reto Sutter, Prof.
Balgrist University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. med. Reto Sutter
Study Record Dates
First Submitted
July 18, 2023
First Posted
August 15, 2023
Study Start
August 7, 2023
Primary Completion (Estimated)
February 29, 2028
Study Completion (Estimated)
February 29, 2028
Last Updated
October 2, 2025
Record last verified: 2025-10