MRI ScansNCT02608944
Comparison of Quantitative MRI Perfusion Methods With Quantitative PET Perfusion Imaging
A study testing Adenosine, Regadenoson and O-15 labeled radioactive water in people with MRI Scans, run by University of Utah at 1 site in United States.
Trial summary
This work seeks to develop, evaluate and use new MRI methods for non-invasive quantitative assessment of myocardial perfusion and perfusion reserve (MPR), and to compare with quantitative PET imaging. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MRI Scans
- What is being tested?
- Adenosine, Regadenoson and O-15 labeled radioactive water
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2012to 12 Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants will be over the age of 18 and able to provide consent
- Both healthy and subjects with cardiac disease (including atrial fibrillation but not required) will be recruited.
Who cannot join
- Critically ill patients, patients on ventilators, patients with unstable angina or with hypotension, asthmatics, and other patients whose medical care or safety may be at risk from undergoing an MRI examination will be excluded.
- Patients with claustrophobia will also be excluded from the study if this cannot be controlled with standard methods (valium or benadryl).
- Patients with contraindication to MRI (pacemaker, metal implants, or certain types of heart valves),
- pregnant patients, minors, mentally disabled patients and prisoners will be excluded from this study. (All criteria apply to patients and normal volunteers).
- Gadolinium nephrotoxicity will be addressed by having patients with abnormal kidney function (GFR<30) excluded from the study due to the (very small) risk associated with gadolinium contrast agents. This threshold may be modified, depending on practices determined by the Radiology Department and the IRB.
- Patients with a known allergy or contraindication to Adenosine and/or Regadenoson will be excluded from stress (hyperemia) cohorts.
- All participants that will receive a stress agent will refrain from consuming caffeine for at least 12 hours prior to each study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah, Radiology Research
Salt Lake City, Utah, 84108
About this study
Official title: Comparison of New MRI Methods for Quantitative Assessment of Myocardial Perfusion With Quantitative PET Perfusion Imaging
This work seeks to develop, evaluate and use new MRI methods for non-invasive quantitative assessment of myocardial perfusion and perfusion reserve (MPR), and to compare with quantitative PET imaging.
Read the detailed description
This project aims to determine the validity of quantitative MRI perfusion methods by comparison with quantitative PET imaging. First pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson. After custom reconstruction and post-processing the data will be fit to a compartment model and quantitative perfusion and MPR values obtained.
On another day, the subjects will have quantitative PET imaging with O-15 labeled radioactive water. This will be done at rest and hyperemia caused by either adenosine or regadenoson. A low dose CT scan will be acquired to perform attenuation correction of the PET images. The images will be reconstructed and processed as reported in the literature to provide reference standard perfusion and MPR values. These values will be compared with those obtained by MRI.
- Conditions
- MRI Scans
- Being tested
- Adenosine, Regadenoson, O-15 labeled radioactive water, MRI, PET Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
Also called Adenoscan, Adenocard
Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion
RegadenosonDrug
Also called Lexiscan
Regadenoson: 0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.
O-15 labeled radioactive waterDrug
Also called O-15 water
O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging
MRIDevice
Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson
PET ImagingDevice
Also called Positron Emission Tomography Imaging
Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day.
| Study group | Role | What they receive |
|---|---|---|
| MRI perfusion vs. PET Imaging perfusion | Experimental | Adenosine Regadenoson O-15 labeled radioactive water MRI PET Imaging Receives: Drug: Adenosine; Drug: Regadenoson; Drug: O-15 labeled radioactive water; Device: MRI; Device: PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion values from MRI
Myocardial perfusion in segments and coronary territories will be computed in ml/min/g from the dynamic MRI data. The perfusion values will be compared to PET data to determine how similar the values are.
Measured: The scan will take ~1-2 hours. The MRI will be done within 2 months of the PET scan.
Myocardial perfusion values from PET
Myocardial perfusion in segments and coronary territories will be computed in ml/min/g from the dynamic PET data. The perfusion values will be compared to MRI data to determine how similar the values are.
Measured: The scan will take ~1-2 hours. The PET scan will be done within 2 months of the MRI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start30 Sep 2012
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
Why it stopped: MRI perfusion techniques development took longer than expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRI ScansStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward DiBella, University of Utah
- Investigators
- Edward DiBella, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608944
- Sponsor's protocol ID
- IRB 58133
- Status last verified
- Sep 2020
- First submitted
- 10 Nov 2015
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of New MRI Methods for Quantitative Assessment of Myocardial Perfusion With Quantitative PET Perfusion Imaging
- ClinicalTrials.gov ID
- NCT02608944
- Acronym / sponsor ID
- IRB 58133
- Conditions
- MRI Scans
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: MRI perfusion techniques development took longer than expected.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 30 Sep 2012 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 20 Nov 2015 (estimated)
- 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 work seeks to develop, evaluate and use new MRI methods for non-invasive quantitative assessment of myocardial perfusion and perfusion reserve (MPR), and to compare with quantitative PET imaging.
Detailed description
This project aims to determine the validity of quantitative MRI perfusion methods by comparison with quantitative PET imaging. First pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson. After custom reconstruction and post-processing the data will be fit to a compartment model and quantitative perfusion and MPR values obtained.
On another day, the subjects will have quantitative PET imaging with O-15 labeled radioactive water. This will be done at rest and hyperemia caused by either adenosine or regadenoson. A low dose CT scan will be acquired to perform attenuation correction of the PET images. The images will be reconstructed and processed as reported in the literature to provide reference standard perfusion and MPR values. These values will be compared with those obtained by MRI.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI perfusion vs. PET Imaging perfusion | Experimental | Drug: Adenosine, Drug: Regadenoson, Drug: O-15 labeled radioactive water, Device: MRI, Device: PET ImagingAdenosine Regadenoson O-15 labeled radioactive water MRI PET Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
Key exclusion criteria (7 listed)
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 |
|---|---|---|
| AdenosineAlso: Adenoscan, AdenocardAdenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion | Drug | MRI perfusion vs. PET Imaging perfusion |
| RegadenosonAlso: LexiscanRegadenoson: 0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion. | Drug | MRI perfusion vs. PET Imaging perfusion |
| O-15 labeled radioactive waterAlso: O-15 waterO-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging | Drug | MRI perfusion vs. PET Imaging perfusion |
| MRIPass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson | Device | MRI perfusion vs. PET Imaging perfusion |
| PET ImagingAlso: Positron Emission Tomography ImagingQuantitative PET imaging with O-15 labeled radioactive water will be given at a different day. | Device | MRI perfusion vs. PET Imaging perfusion |
Primary outcome
Myocardial perfusion values from MRI
Time frame: The scan will take ~1-2 hours. The MRI will be done within 2 months of the PET scan.
Myocardial perfusion in segments and coronary territories will be computed in ml/min/g from the dynamic MRI data. The perfusion values will be compared to PET data to determine how similar the values are.
Myocardial perfusion values from PET
Time frame: The scan will take ~1-2 hours. The PET scan will be done within 2 months of the MRI.
Myocardial perfusion in segments and coronary territories will be computed in ml/min/g from the dynamic PET data. The perfusion values will be compared to MRI data to determine how similar the values are.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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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.
Edward DiBella, Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenosine, Regadenoson and O-15 labeled radioactive water in people with MRI Scans, run by University of Utah 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 14 Sep 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Myocardial perfusion values from MRI (time frame: The scan will take ~1-2 hours. The MRI will be done within 2 months of the PET scan.). The study lists 2 primary outcomes in all. 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 14 Sep 2020.