PET-MR Diagnostic
Conditions
Interventions
Group 1: Single PET-MR examination with an examination time of max. 30-45 minutes
Sponsors
Siemens Healthineers AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients of legal age for whom a PET-CT examination is indicated and will be performed - Patients of legal age who have given their written informed consent to participate in the clinical trial - Written consent of the patient to be informed in the event of suspected clinically relevant incidental findings - written consent to the disclosure of a clinically relevant incidental finding to a subsequent physician (release from the duty of confidentiality) - The patient's written consent that the recorded image data may be made available to Siemens Healthineers AG in pseudonymized form - Patients whose weight does not exceed the permissible weight limit of the patient table (200 kg).
Exclusion criteria
Exclusion criteria: - metal in and on the body that leads to exposure of the subject during an examination in the FoV of the combined PET-MR system - all pacemakers and other implants from different manufacturers that are not labeled as MR safe or MR conditional - Pregnancy: The exclusion of study participants of childbearing potential is carried out by questioning to ensure that only study participants who are in the first half of their menstrual cycle may be included. In case of doubt, the study will not be conducted. - Persons who indicate an increased sensitivity to loud noises - Persons who are not of legal age or incapable of giving consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the diagnostic image quality (software and hardware) of the novel combined PET-MR system NextGen PET-MR in the clinical setting. Evaluation is carried out after the PET-MR examination by nuclear medicine physicians and radiologists using a 5-point Likert scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of diagnostic image quality, image resolution and image post-processing Evaluation of the diagnosability of routine examinations in different body regions Comparison to current state-of-the-art hybrid examinations on PET-CT or PET-MR Investigation of clinical safety and possible occurrence of adverse events Evaluation of the additional requirements for the hybrid examination as defined in the scope of the investigation Patient Comfort Assessment Evaluation of system stability, performance, and safety in the clinical setting Evaluation is carried out after the PET-MR examination by nuclear medicine physicians and radiologists using a 5-point Likert scale. | — |
Countries
Germany
Contacts
Public ContactMichael Beck
Universitätsklinikum Erlangen
Outcome results
None listed