The New Combined PET-MR System NextGen PET-MR With Syngo MR XA80A: Evaluation of Diagnostic Image Quality and Usability (Software and Hardware) in the Clinical Setting.

Last updated: April 22, 2026
Sponsor: Siemens Healthcare A/S
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

PET-MR examination

Clinical Study ID

NCT06666387
11723119-AVE-V02
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult test subjects for whom a PET-MR examination is indicated and will beperformed, or

  • Test subjects for whom a PET-CT examination is indicated and will be performed

  • Test subjects of legal age who have given their written informed consent toparticipate in the clinical investigation

  • Written consent of the test subject to be informed in the event of suspectedclinically relevant incidental findings

  • Written consent to the disclosure of a clinically relevant incidental finding to asubsequent physician (release from the duty of confidentiality)

  • The test subject´s written consent that the recorded image data may be madeavailable to Siemens Healthcare A/S in pseudonymized form

  • Test subjects whose weight does not exceed the permissible weight limit of thepatient table (200 kg).

Exclusion

Exclusion Criteria:

  • Metal in and on the body that causes stress to the test subject during anexamination in the FoV of the combined PET-MR system

  • All pacemakers and other implants

  • Pregnancy: The exclusion of test subjects of childbearing potential is carried outbased on a positive pregnancy test

  • Test subjects who indicate an increased sensitivity to loud noises

  • Test subjects who are incapable of giving consent.

Study Design

Total Participants: 65
Treatment Group(s): 1
Primary Treatment: PET-MR examination
Phase:
Study Start date:
October 31, 2024
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

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