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Feasibility Testing of 7-Tesla Magnetic Resonance Imaging

Sponsor
Reto Sutter, MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05992298
Collaborator
(none)
780
Enrollment
1
Location
1
Arm
6.8
Anticipated Duration (Months)
115.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 7 T MRI vs 3 T MRI
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
780 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Explorative Technical Feasibility Testing of 7-Tesla Magnetic Resonance Imaging of the Musculoskeletal System and of the Head
Anticipated Study Start Date :
Aug 7, 2023
Anticipated Primary Completion Date :
Feb 29, 2024
Anticipated Study Completion Date :
Feb 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 7 T MRI

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Balgrist University Hospital Zurich Switzerland 8008

Sponsors and Collaborators

  • Reto Sutter, MD

Investigators

  • Principal Investigator: Reto Sutter, Prof., Balgrist University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Reto Sutter, MD, Prof. Dr. med. Reto Sutter, Balgrist University Hospital
ClinicalTrials.gov Identifier:
NCT05992298
Other Study ID Numbers:
  • I0171
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 15, 2023