MR diagnostic of the head, knee, and hand/wrist in patients with a clinical indication, using a 7-Tesla MRI system with new software, including the use of contrast agents if clinically indicated.
Conditions
Interventions
Group 1: Single MR examination with a scan duration of a maximum of 90 minutes for Phase A (healthy volunteers) and a maximum of 45 minutes for Phase B (patients). There is no additional control group
the investigators evaluate the result alone (single-arm study) and the investigators know the complete investigational product (not a blind study)
Sponsors
Siemens Healthineers AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Healthy adult volunteers who have submitted their written declaration of consent to participate in the clinical investigation after comprehensive information - Healthy adult volunteers who, through their written consent, have decided for or against being informed in the event of a suspected clinically relevant incidental finding, and thus also for or against the disclosure of such an incidental finding to a follow-up physician - Adult patients who have submitted their written declaration of consent to participate in the clinical investigation after comprehensive information - Patients with a clinical indication for an MRI examination, including the potential use of contrast agents if medically indicated - Patients and volunteers whose weight does not exceed the permissible weight restriction of the patient table (200 kg) - The written consent form of the patient and/or volunteer, confirming that the acquired imaging data may be provided to Siemens Healthineers AG in pseudonymized form
Exclusion criteria
Exclusion criteria: - Metal in or on the body that may cause harm to the study participant during an examination within the field of view (FoV) of the MAGNETOM Terra.X MRI system - All pacemakers and other implants from different manufacturers that are not labeled as MR safe or MR conditional - Pregnancy: Exclusion of women of childbearing potential is ensured by questioning, to confirm that only participants in the first half of the menstrual cycle are included. In case of doubt, the examination will not be performed - Individuals who report increased sensitivity to loud noise - Participants with claustrophobia - Persons who are not of legal age or incapable of giving consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of diagnostic image quality and the quality of spectra and CEST images, as well as the usability of head, knee, and hand/wrist examinations in a clinical environment. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Assessment of the general image quality, image resolution, and image post-processing • Optimization of examination protocols according to clinical routine requirements • Assessment of functionality and documentation of time-related parameters, such as the duration of the examination • General assessment of patient comfort during clinical examinations • Assessment of system stability, performance, and safety in the clinical setting • Assessment of new surface coils, e.g. coverage of the anatomical region of interest and patient comfort | — |
Countries
Germany
Contacts
Public ContactMichael Uder
Universitätsklinik Erlangen, Radiologisches Institut
Outcome results
None listed