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This clinical investigation is used to evaluate the novel PET-MR scanner and it is a clinical investigation under MDR.
The focus is on the evaluation of the diagnostic image quality in a clinical setting, considering the speed of the examination and the new functionalities to minimize the patient's lying times. Based on the assessment, the defined protocols and measurement sequences are further improved as necessary to optimize the clinical value of the sequences and user interface components.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET-MR examination | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET-MR examination | Diagnostic Test | PET-MR examination |
|
| Measure | Description | 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. | The outcome of this clinical investigation for conformity assessment according to §62 MDR is the performance and safety to show the indirect clinical benefit. The performance includes diagnostic image quality (including general image quality of the software features, resolution, occurrence of artifacts, etc.) as well as the functionality including system stability of the novel PET-MR system in the clinical setting. The diagnostic image quality, image noise, contrast and resolution for each acquired sequence is rated by two investigators of each specialization (nuclear medicine and radiology) using a 5-point Likert scale. The rating is done for MR images of body regions whole body, total body, brain, head/neck and pelvis fused with PET images of different tracers for all participants. The test in a region of the body is considered successful if the mean value of all scores in that region reaches a value of t ≤ 2.5. In case the mean value for a certain software feature does not reach 2. | Estimated 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
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