Cardiac DiseaseNCT02062008
Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications
A study testing PET-MRI in people with Cardiac Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to understand how simultaneous PET/MR acquisition can provide novel qualitative and quantitative biomarkers to guide clinical intervention and predict prognosis of patients with cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- PET-MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 10 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with ischemic and non-ischemic cardiac disease referred for cardiac PET for viability imaging.
Who cannot join
- Contraindications for MRI, including cardiac pacemaker, claustrophobia, retained metallic foreign body, cochlear implant, Aneurysm clip in the brain, pregnancy and eGFR less than 45%.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF University of California in San Francisco
San Francisco, California, 94107
About this study
The purpose of this study is to understand how simultaneous PET/MR acquisition can provide novel qualitative and quantitative biomarkers to guide clinical intervention and predict prognosis of patients with cardiovascular disease.
Read the detailed description
- To compare regional myocardial uptake of FDG on images obtained on a standard PET camera with the new PET/MR camera, in patients with coronary artery disease.
- To compare viability maps obtained with cardiac MR images and FDG-PET for delineation of myocardial infarct core and border zone, in patients with coronary artery disease.
- To correlate MRI myocardial strain with relative myocardial FDG uptake in patients with a previous myocardial infarction.
- To interrogate if simultaneous acquisition of cardiac PET and viability cardiac MR differ from acquisitions obtained independently, with special focus on attenuation correction methods
- To combined MRI scar map with FDG-PET uptake in patients with cardiac sarcoidosis and myocarditis.
- To correlate morphologic characteristics of atherosclerotic disease in the thoracic and abdominal aorta with FDG uptake and ferumoxytol enhancement, as a marker of inflammation.
- To evaluate cardiac strain and myocardial scar burden in obese patients with and without diabetes.
- Conditions
- Cardiac Disease
- Being tested
- PET-MRI
- Keywords
- Positron Emission Tomography-Magnetic Resonance Imaging, Cardiac Disease
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRIDevice
PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac patients receiving PET/MR | Other | PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. Receives: Device: PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Quality PET and PET/MR Images With Regional Myocardial Uptake of 18F-Fluorodeoxyglucose (FDG) in Participants Without Overt Diagnosis of Ischemic Coronary Artery Disease.
Visual analysis of collected image pairs. Evaluated by experienced imaging providers as yes or no.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startDec 2016
- Primary completion10 Feb 2018
- Study completion10 Feb 2018
Why it stopped: Lack of funding to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen G Ordovas, MD,MAS, Principal investigator, Assistent Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062008
- Sponsor's protocol ID
- Combined PET-MRI
- Status last verified
- May 2021
- First submitted
- 7 Feb 2014
- Last updated
- 16 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications
- ClinicalTrials.gov ID
- NCT02062008
- Acronym / sponsor ID
- Combined PET-MRI
- Conditions
- Cardiac Disease
- Keywords
- Positron Emission Tomography-Magnetic Resonance Imaging, Cardiac Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding to continue.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 10 Feb 2018 (actual)
- Study completion
- 10 Feb 2018 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Posted 16 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand how simultaneous PET/MR acquisition can provide novel qualitative and quantitative biomarkers to guide clinical intervention and predict prognosis of patients with cardiovascular disease.
Detailed description
- To compare regional myocardial uptake of FDG on images obtained on a standard PET camera with the new PET/MR camera, in patients with coronary artery disease.
- To compare viability maps obtained with cardiac MR images and FDG-PET for delineation of myocardial infarct core and border zone, in patients with coronary artery disease.
- To correlate MRI myocardial strain with relative myocardial FDG uptake in patients with a previous myocardial infarction.
- To interrogate if simultaneous acquisition of cardiac PET and viability cardiac MR differ from acquisitions obtained independently, with special focus on attenuation correction methods
- To combined MRI scar map with FDG-PET uptake in patients with cardiac sarcoidosis and myocarditis.
- To correlate morphologic characteristics of atherosclerotic disease in the thoracic and abdominal aorta with FDG uptake and ferumoxytol enhancement, as a marker of inflammation.
- To evaluate cardiac strain and myocardial scar burden in obese patients with and without diabetes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac patients receiving PET/MR | Other | Device: PET-MRIPET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with ischemic and non-ischemic cardiac disease referred for cardiac PET for viability imaging.
Key exclusion criteria (1 listed)
- Contraindications for MRI, including cardiac pacemaker, claustrophobia, retained metallic foreign body, cochlear implant, Aneurysm clip in the brain, pregnancy and eGFR less than 45%.
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-MRIPET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. | Device | Cardiac patients receiving PET/MR |
Primary outcome
Number of Quality PET and PET/MR Images With Regional Myocardial Uptake of 18F-Fluorodeoxyglucose (FDG) in Participants Without Overt Diagnosis of Ischemic Coronary Artery Disease.
Time frame: 2 hours
Visual analysis of collected image pairs. Evaluated by experienced imaging providers as yes or no.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Karen G Ordovas, MD,MAS principal investigator
Assistent Professor
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-MRI in people with Cardiac Disease, run by University of California, San Francisco at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 16 Jun 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Quality PET and PET/MR Images With Regional Myocardial Uptake of 18F-Fluorodeoxyglucose (FDG) in Participants Without Overt Diagnosis of Ischemic Coronary Artery Disease. (time frame: 2 hours). 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 16 Jun 2021.