Cardiac ImagingNCT03200132
Respiratory Motion Correction of Cardiac Combined Positron Emission Tomography and Magnetic Resonance Imaging (PET/MRI)
An observational study of Cardiac Imaging, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This study evaluates the possibility of Magnetic Resonance Imaging (MRI) based respiratory motion correction of simultaneously acquired cardiac Positron Emission Tomography (PET) images. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Imaging
- What is being tested?
- Cardiac PET/MRI
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Jun 2017to 14 Oct 2021
- Phase
- Observational
- 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
Study population: All patients receiving 18F-FDG for clinical diagnostic PET/MRI or PET/CT.
Who may be able to join
- 18F-FDG injection for clinical diagnostic PET/MRI or PET/CT
Who cannot join
- Diet-suppressed myocardial uptake of 18F-FDG
- General exclusion criteria for MRI (i.e. metallic implants, claustrophobia, pregnancy, etc.)
- Not willing to be informed about incidental findings
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Hospital
Maastricht, Limburg, 6229HX
About this study
This study evaluates the possibility of Magnetic Resonance Imaging (MRI) based respiratory motion correction of simultaneously acquired cardiac Positron Emission Tomography (PET) images.
- Conditions
- Cardiac Imaging
- Being tested
- Cardiac PET/MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac PET/MRIDiagnostic test
For patients undergoing 18-Fluor- fluorodeoxyglucose (18F-FDG) PET/MRI or PET/Computed Tomography (CT), additional cardiac PET/MRI scans are acquired.
What is being measured
The primary outcome is the main question the study is designed to answer.
Target-to-background ratio (TBR)
Measured: 15-20 minutes
Secondary outcomes (1)
Signal-to-noise ratio (SNR)
Measured: 15-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start26 Jun 2017
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ImagingStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joachim Wildberger, MD PhD, Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200132
- Sponsor's protocol ID
- 16-4-156
- Status last verified
- Apr 2022
- First submitted
- 26 Jun 2017
- Last updated
- 8 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Motion Correction of Cardiac Combined Positron Emission Tomography and Magnetic Resonance Imaging (PET/MRI)
- ClinicalTrials.gov ID
- NCT03200132
- Acronym / sponsor ID
- 16-4-156
- Conditions
- Cardiac Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 27 Jun 2017 (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 study evaluates the possibility of Magnetic Resonance Imaging (MRI) based respiratory motion correction of simultaneously acquired cardiac Positron Emission Tomography (PET) images.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving 18F-FDG for clinical diagnostic PET/MRI or PET/CT.
Key inclusion criteria (1 listed)
- 18F-FDG injection for clinical diagnostic PET/MRI or PET/CT
Key exclusion criteria (3 listed)
- Diet-suppressed myocardial uptake of 18F-FDG
- General exclusion criteria for MRI (i.e. metallic implants, claustrophobia, pregnancy, etc.)
- Not willing to be informed about incidental findings
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 |
|---|---|---|
| Cardiac PET/MRIFor patients undergoing 18-Fluor- fluorodeoxyglucose (18F-FDG) PET/MRI or PET/Computed Tomography (CT), additional cardiac PET/MRI scans are acquired. | Diagnostic test | – |
Primary outcome
Target-to-background ratio (TBR)
Time frame: 15-20 minutes
1 secondary outcome
Signal-to-noise ratio (SNR)
Time frame: 15-20 minutes
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 8 Apr 2022.
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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.
Joachim Wildberger, MD PhD principal investigator
Maastricht University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Imaging, run by Maastricht University Medical Center at 1 site in Netherlands.
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 1 inclusion and 3 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 8 Apr 2022. 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 Netherlands. 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?
Target-to-background ratio (TBR) (time frame: 15-20 minutes). 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 8 Apr 2022.