Evaluation of a new combined PET-MR imaging system
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.
This study is testing a new PET-MR scanner to see if it can provide better images and make the scanning process quicker and more comfortable for adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Siemens Healthcare A/S Industry-sponsored |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06666387 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates a novel PET-MR scanner to assess its diagnostic image quality and usability in a clinical setting. The study focuses on improving examination speed and minimizing patient lying times through enhanced functionalities. Based on the evaluation, protocols and measurement sequences will be optimized to maximize clinical value and user interface components. The study involves conducting PET-MR examinations on eligible adult participants.
Who should consider this trial
Good fit: Ideal candidates include adults requiring a PET-MR or PET-CT examination who can provide informed consent.
Not a fit: Patients with metal implants or pacemakers that interfere with the PET-MR system may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved diagnostic imaging quality and efficiency for patients undergoing PET-MR examinations.
How similar studies have performed: While this approach is innovative, similar studies evaluating advanced imaging technologies have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Siemens Healthcare A/S
- Email: dkclinicalinvestigation.team@siemens-healthineers.com
- Phone: +45 4477 4477
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.