MR diagnostics if there is a clinical indication for a needle-guided intervention and, if necessary, drug therapy of the facet joints or for a cardiac MRI with medically indicated contrast agent administration (if necessary).
Conditions
Interventions
Group 1: One-time MR examination with an examination time of max. 20 minutes for phase A (healthy volunteers) or a maximum of 30-60 minutes for phase B (patients). There is no additional control group
Sponsors
Siemens Healthineers AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: •Healthy adult volunteers who have given their written informed consent to participate in the clinical trial after comprehensive information •Healthy adult volunteers who have decided by their written consent for or against notification in the event of suspicion of a clinically relevant incidental finding and thus also for or against the disclosure of a clinically relevant incidental finding to a follow-up physician. •Adult patients who have given their written informed consent to participate in the clinical trial after comprehensive information •Adult patients who have a clinical indication for a needle-guided intervention or for a cardiac MRI with medically indicated contrast agent administration if necessary •Patients and volunteers whose weight does not exceed the permissible weight limit of the patient table (320 kg). •The written consent of the patient or volunteer that the recorded image data may be made available to Siemens Healthineers AG in pseudonymized form.
Exclusion criteria
Exclusion criteria: •Congenital or drug-induced coagulation disorders that are incompatible with minimally invasive surgery according to international guidelines. •Allergic reactions to local narcotics. •Insufficient patient compliance for MRI-guided intervention •Metal in and on the body, which leads to stress on the examinee during an examination in the FoV of the MAGNETOM eMeRge XL system •All pacemakers and other implants from different manufacturers that are not marked as MR safe or MR conditional. •Pregnancy: Exclusion for women of childbearing potential is done by interviewing to ensure that only participants who are in the first half of the menstrual cycle may be included. In case of doubt, an examination is dispensed with. •People who report increased sensitivity to loud noises. •Persons who are not of legal age or persons who are incapable of giving consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the diagnostic image quality of cardiovascular examinations and clinical functionality of needle-guided interventions with the new MR whole-body system MAGNETOM eMeRge XL with Numaris/X. All images taken, examination procedures and the procedures of the different types of interventions are qualitatively assessed by the investigators in questionnaires (CRFs). The evaluation is carried out using a Likert scale with the evaluation steps from 1 (++) to 5 (--). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Evaluation of general image quality, image resolution and image post-processing • Optimisation of examination protocols to the requirements of clinical routine • Evaluation of functionality and recording of time parameters, such as the duration of needle-guided interventions • Overall assessment of comfort during patient examinations • Evaluation of system stability, performance and safety in the clinical environment • Evaluation of new surface coils such as exam area coverage and patient comfort | — |
Countries
Germany
Contacts
Public ContactMichael Uder
Universitätsklinik Erlangen, Radiologisches Institut
Outcome results
None listed