Cardiac DiseaseNCT02084147
PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases
A study testing positron emission tomography, computed tomography and magnetic resonance imaging in people with Cardiac Disease and Dementia, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies how well positron emission tomography (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Dementia, Inflammatory Disease
- What is being tested?
- positron emission tomography, computed tomography and magnetic resonance imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2013to 2 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically indicated PET/PET-CT (with or without clinically indicated diagnostic MRI)
- Presenting with one of the four conditions specified below
- Fludeoxyglucose F 18 (FDG) avid cancers
- Cardiac disease (cardiac viability assessment)
- Neurologic disorders (dementia)
- Inflammatory disease (for example fever of unknown origin, vasculitis, osteomyelitis)
Who cannot join
- Pregnancy and lactation
- Contraindications to undergo MRI
- Cardiac pacemaker and metal devices (as specified in a separate MRI Informed consent)
- Claustrophobia or inability to tolerate MRI examination (lay still for approximately 1 hour and hold breath intermittently)
- Previously known allergies against MRI contrast agents (exclusion criterion only for contrast enhanced MRI)
- Renal insufficiency: glomerular filtration rate (GFR) < 40ml/min/1.73m^2 and following European Society of Urogenital Radiology (ESUR) guidelines (exclusion criterion only for contrast enhanced MRI)
- Individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent)
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: PET-MRI: Evaluation, Optimization and Clinical Implementation
This randomized pilot clinical trial studies how well positron emission tomography (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases. PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI is similar to standard-of-care PET-CT, but exposes the patient to less radiation. It is not yet known whether PET-MRI produces better image quality than PET-CT in diagnosing patients with cancer, cardiac disease, or neurologic disease.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess and optimize image quality of PET and MRI focusing on technical artifacts and their correction.
II. To assess the accuracy of PET quantification based on MR attenuation correction (MRAC) derived from various MRI sequences and reconstruction algorithms including the effect of routinely used Gadolinium-based contrast agents on MRAC.
III. To determine the clinical and diagnostic accuracy of PET-MRI in comparison to standard-of-care diagnostic imaging.
IV. To assess the efficacy and workflow in combining PET and MRI in one single examination as compared to separate imaging studies.
- To assess the potential for radiation dose reduction if PET-CT is substituted by PET-MRI, thus avoiding the radiation exposure from the CT-component.
- Conditions
- Cardiac Disease, Dementia, Inflammatory Disease, Fever of Unknown Origin, Vasculitis, Osteomyelitis
- Being tested
- positron emission tomography, computed tomography, magnetic resonance imaging
- Medical subject headings
- Heart Diseases, Dementia, Fever of Unknown Origin, Vasculitis, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positron emission tomographyDevice
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo PET
computed tomographyDevice
Also called tomography, computed, CT
Undergo CT
magnetic resonance imagingDevice
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo MRI
| Study group | Role | What they receive |
|---|---|---|
| PET-CT and PET-MRI | Experimental | Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes. Receives: Device: positron emission tomography; Device: computed tomography; Device: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Image Quality Scores
Overall image quality scores obtained from the two imaging modalities will be compared with the hypothesis that hybrid PET-MRI images is as good as PET-CT images or superior (not inferior) to the PET-CT images. Evaluation of overall image quality will be assessed using the following criteria: 1=excellent, 2=good, 3=acceptable, 4=poor, 5=not acceptable. A Wilcoxon (Mann-Whitney) rank-sum test with a 0.100 significance level will be used.
Measured: Day 1
Lesion Based Standard Uptake Values (SUV)
Lesion based SUV will be estimated and compared for PET-MR and PET-CT images in normal organs and compared. A two-sided two-sample t-test will be used to show significance of difference.
Measured: Day 1
Area Under the Receiver Operating Characteristic Curve
A two-sided z-test will be used to detect the difference in the area under the curve showing the sensitivity, specificity, positive and negative predictive values as well as accuracy of diagnostic information.
Measured: Day 1
Time Effort Associated With the PET-MRI Versus PET-CT With MRI
Statistical difference in time between PET-MRI versus sequential approach for PET-CT plus MRI. Workflow with shortest timely efforts and sufficient diagnostic information will be established as routine procedure.
Measured: Day 1
Radiation Dose Reduction With PET-MRI
Dose measurements will be used to calculate effective radiation dose in each patient. Dose calculations of effective dose will be used to estimate dose savings in omitting the CT component of PET-CT. Statistical tests will use a 0.10 significance level and will be 2-sided
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study start7 Mar 2013
- Primary completion14 Sep 2016
- Study completion2 Oct 2018
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 Case Comprehensive Cancer 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Pablo Ros, MD, MPH, PhD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084147
- Sponsor's protocol ID
- CASE16Z12
- Other IDs
- NCI-2014-00376, CASE16Z12, P30CA043703
- Status last verified
- Oct 2019
- First submitted
- 7 Mar 2014
- Last updated
- 29 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-MRI: Evaluation, Optimization and Clinical Implementation
- ClinicalTrials.gov ID
- NCT02084147
- Acronym / sponsor ID
- CASE16Z12
- Conditions
- Cardiac Disease, Dementia, Inflammatory Disease, Fever of Unknown Origin, Vasculitis, Osteomyelitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Mar 2013 (actual)
- Primary completion
- 14 Sep 2016 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Posted 29 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot clinical trial studies how well positron emission tomography (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases. PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI is similar to standard-of-care PET-CT, but exposes the patient to less radiation. It is not yet known whether PET-MRI produces better image quality than PET-CT in diagnosing patients with cancer, cardiac disease, or neurologic disease.
Detailed description
PRIMARY OBJECTIVES:
- To assess and optimize image quality of PET and MRI focusing on technical artifacts and their correction.
II. To assess the accuracy of PET quantification based on MR attenuation correction (MRAC) derived from various MRI sequences and reconstruction algorithms including the effect of routinely used Gadolinium-based contrast agents on MRAC.
III. To determine the clinical and diagnostic accuracy of PET-MRI in comparison to standard-of-care diagnostic imaging.
IV. To assess the efficacy and workflow in combining PET and MRI in one single examination as compared to separate imaging studies.
- To assess the potential for radiation dose reduction if PET-CT is substituted by PET-MRI, thus avoiding the radiation exposure from the CT-component.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-CT and PET-MRI | Experimental | Device: positron emission tomography, Device: computed tomography, Device: magnetic resonance imagingPatients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically indicated PET/PET-CT (with or without clinically indicated diagnostic MRI)
- Presenting with one of the four conditions specified below
Key exclusion criteria (7 listed)
- Pregnancy and lactation
- Contraindications to undergo MRI
- Cardiac pacemaker and metal devices (as specified in a separate MRI Informed consent)
- Claustrophobia or inability to tolerate MRI examination (lay still for approximately 1 hour and hold breath intermittently)
- Previously known allergies against MRI contrast agents (exclusion criterion only for contrast enhanced MRI)
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 |
|---|---|---|
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo PET | Device | PET-CT and PET-MRI |
| computed tomographyAlso: tomography, computed, CTUndergo CT | Device | PET-CT and PET-MRI |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo MRI | Device | PET-CT and PET-MRI |
Primary outcome
Overall Image Quality Scores
Time frame: Day 1
Overall image quality scores obtained from the two imaging modalities will be compared with the hypothesis that hybrid PET-MRI images is as good as PET-CT images or superior (not inferior) to the PET-CT images. Evaluation of overall image quality will be assessed using the following criteria: 1=excellent, 2=good, 3=acceptable, 4=poor, 5=not acceptable. A Wilcoxon (Mann-Whitney) rank-sum test with a 0.100 significance level will be used.
Lesion Based Standard Uptake Values (SUV)
Time frame: Day 1
Lesion based SUV will be estimated and compared for PET-MR and PET-CT images in normal organs and compared. A two-sided two-sample t-test will be used to show significance of difference.
Area Under the Receiver Operating Characteristic Curve
Time frame: Day 1
A two-sided z-test will be used to detect the difference in the area under the curve showing the sensitivity, specificity, positive and negative predictive values as well as accuracy of diagnostic information.
Time Effort Associated With the PET-MRI Versus PET-CT With MRI
Time frame: Day 1
Statistical difference in time between PET-MRI versus sequential approach for PET-CT plus MRI. Workflow with shortest timely efforts and sufficient diagnostic information will be established as routine procedure.
Radiation Dose Reduction With PET-MRI
Time frame: Day 1
Dose measurements will be used to calculate effective radiation dose in each patient. Dose calculations of effective dose will be used to estimate dose savings in omitting the CT component of PET-CT. Statistical tests will use a 0.10 significance level and will be 2-sided
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- 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.
Pablo Ros, MD, MPH, PhD principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positron emission tomography, computed tomography and magnetic resonance imaging in people with Cardiac Disease and Dementia, run by Case Comprehensive Cancer Center 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 6 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: finished, as of the sponsor's last update on 29 Oct 2019. 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 29 Oct 2019). 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?
Overall Image Quality Scores (time frame: Day 1). The study lists 5 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 29 Oct 2019.