PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases
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|ClinicalTrials.gov Identifier: NCT02084147|
Recruitment Status : Suspended (Interim Analysis)
First Posted : March 11, 2014
Last Update Posted : October 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Disease Dementia Inflammatory Disease Fever of Unknown Origin Vasculitis Osteomyelitis FDG Avid Cancers||Device: positron emission tomography Device: computed tomography Device: magnetic resonance imaging||Not Applicable|
I. 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.
V. 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||530 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PET-MRI: Evaluation, Optimization and Clinical Implementation|
|Actual Study Start Date :||March 7, 2013|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: PET-CT and PET-MRI
Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.
Device: positron emission tomography
Other Names:Device: computed tomography
Other Names:Device: magnetic resonance imaging
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084147
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Pablo Ros, MD, MPH, PhD||Case Comprehensive Cancer Center|