Feasibility Testing of 7-Tesla Magnetic Resonance Imaging

NCT ID: NCT05992298

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

780 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2028-02-29

Brief Summary

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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

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Conditions

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Magnetic Resonance Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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7 T MRI

Group Type EXPERIMENTAL

7 T MRI vs 3 T MRI

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Reto Sutter, MD

OTHER

Sponsor Role lead

Responsible Party

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Reto Sutter, MD

Prof. Dr. med. Reto Sutter

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Reto Sutter, Prof.

Role: PRINCIPAL_INVESTIGATOR

Balgrist University Hospital

Locations

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Balgrist University Hospital

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Reto Sutter, Prof.

Role: CONTACT

+41 44 386 33 08

Daniel Nanz, Prof.

Role: CONTACT

+41 44 510 70 04

Facility Contacts

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Reto Sutter, Prof.

Role: primary

+41 44 386 33 08

Other Identifiers

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I0171

Identifier Type: -

Identifier Source: org_study_id

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