PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases
Fever of Unknown Origin
FDG Avid Cancers
Procedure: positron emission tomography
Procedure: computed tomography
Procedure: magnetic resonance imaging
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||PET-MRI: Evaluation, Optimization and Clinical Implementation|
- Overall image quality scores [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: PET-CT and PET-MRI
Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.
Procedure: positron emission tomography
Other Names:Procedure: computed tomography
Other Names:Procedure: magnetic resonance imaging
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02084147
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106-5065|
|Contact: Pablo Ros 216-983-4829 firstname.lastname@example.org|
|Principal Investigator: Pablo Ros|
|Principal Investigator:||Pablo Ros||Case Comprehensive Cancer Center|