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RecruitingNot ApplicableNCT06666387

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.

Sponsor

Siemens Healthcare A/S

Enrollment

60 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

The Evaluation of a New MD - Combined PET-MR System

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

Min Age: 18 Years

Inclusion Criteria7

  • Adult test subjects for whom a PET-MR examination is indicated and will be performed, 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 to participate in the clinical investigation
  • Written consent of the test subject 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 test subject´s written consent that the recorded image data may be made available to Siemens Healthcare A/S in pseudonymized form
  • Test subjects whose weight does not exceed the permissible weight limit of the patient table (200 kg).

Exclusion Criteria5

  • Metal in and on the body that causes stress to the test subject during an examination 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 out based on a positive pregnancy test
  • Test subjects who indicate an increased sensitivity to loud noises
  • Test subjects who are incapable of giving consent.

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Interventions

DIAGNOSTIC_TESTPET-MR examination

PET-MR examination

Locations(1)

Rigshospitalet

Copenhagen, Denmark

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NCT06666387