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.

Siemens

Status: Enrolling

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

Treatments: Diagnostic Test: PET-MR examination

Study type: Interventional

Funder types: Industry

Identifiers

NCT06666387

11723119-AVE-V02

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

PET-MR examination

Other group

Treatment:

Diagnostic Test: PET-MR examination