The Evaluation of a New MD - Combined PET-MR SystemNCT06666387
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.
A study testing PET-MR examination in people with The Evaluation of a New MD - Combined PET-MR System, run by Siemens Healthcare A/S at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Evaluation of a New MD - Combined PET-MR System
- What is being tested?
- PET-MR examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Oct 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- PET-MR examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MR examinationDiagnostic test
PET-MR examination
| Study group | Role | What they receive |
|---|---|---|
| PET-MR examination | Other | Not described Receives: Diagnostic Test: PET-MR examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Estimated 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start31 Oct 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Evaluation of a New MD - Combined PET-MR SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Healthcare A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666387
- Sponsor's protocol ID
- 11723119-AVE-V02
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06666387
- Acronym / sponsor ID
- 11723119-AVE-V02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Siemens Healthcare A/SIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-MR examination | Other | Diagnostic Test: PET-MR examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-MR examinationPET-MR examination | Diagnostic test | PET-MR examination |
Primary outcome
Evaluation of the diagnostic image quality (software and hardware) of the novel combined PET-MR system NextGen PET-MR in the clinical setting.
Time frame: Estimated 5 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MR examination in people with The Evaluation of a New MD - Combined PET-MR System, run by Siemens Healthcare A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the diagnostic image quality (software and hardware) of the novel combined PET-MR system NextGen PET-MR in the clinical setting. (time frame: Estimated 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.