Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
NCT Number: NCT02287636
This pilot clinical trial studies how well positron emission tomography (PET)/magnetic resonance imaging (MRI) works compared to PET/computed tomography (CT) in diagnosing younger patients with cancer. PET/MRI and PET/CT are procedures that combine the pictures from a PET scan and an MRI scan or a CT scan. The PET and MRI scans or PET and CT scans are done at the same time with the same machine. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. It is not yet known whether PET/MRI works better than PET/CT in diagnosing younger patients with cancer.
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Notify MeUp to 17 year
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44106-5065, United States
PRIMARY OBJECTIVES:
I. Determine the diagnostic accuracy of PET/MRI as compared to the standard of reference PET/CT in lesion detection and lesion characterization.
SECONDARY OBJECTIVES:
I. Obtain quantitative measurements in various body regions of standardized uptake values (SUV) in normal tissue and foci of pathologic tracer uptake in PET/MRI of pediatric patients with oncologic disease using various magnetic resonance attenuation correction (MRAC) methods and compare those to respective SUV based on CT attenuation correction.
II. Assess the potential for radiation dose reduction with PET/MRI when eliminating CT radiation dose.
III. Assess time efforts and workflow improvement with PET/MRI compared to sequential PET/CT plus MRI.
OUTLINE:
Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo fludeoxyglucose F 18 PET/CT
Other names: 18FDG, FDG
Undergo fludeoxyglucose F 18 PET/CT
Other names: FDG-PET, PET, PET scan, tomography, emission computed
Undergo fludeoxyglucose F 18 PET/CT
Other names: tomography, computed
Undergo PET/MRI
Other names: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Time frame: 1 day
Evaluation of the PET/MR imaging platform will be based on the ability to detect lesions. Evaluation of each lesion will be recorded using the following 5 point rating scale: 1=benign, 2=probably benign, 3=indeterminate, 4=probably malignant, 5=malignant. A Wilcoxon (Mann-Whitney) rank-sum test and two-sided z-test will be used to compare diagnostic accuracy of PET/MRI with PET/CT.
Time frame: 1 day
Evaluation of the PET/CT imaging platform will be based on the ability to detect lesions. Evaluation of each lesion will be recorded using the following 5 point rating scale: 1=benign, 2=probably benign, 3=indeterminate, 4=probably malignant, 5=malignant. A Wilcoxon (Mann-Whitney) rank-sum test and two-sided z-test will be used to compare diagnostic accuracy of PET/CT with PET/MRI.
Time frame: 1 day
The means and standard deviations of SUVs will be obtained and compared between PET/MRI and PET/CT using a two-sided two-sample t-test.
Time frame: 1 day
The means and standard deviations of SUVs will be obtained and compared between PET/MRI and PET/CT using a two-sided two-sample t-test.
Time frame: 1 day
Tabulations of summary statistics, graphical presentations, and statistical analyses will be performed. Statistical tests will use a 0.10 significance level and will be 2-sided unless otherwise noted. Confidence intervals, both individual and simultaneous, will be at 90% confidence level unless stated otherwise.
Time frame: 1 day
Tabulations of summary statistics, graphical presentations, and statistical analyses will be performed. Statistical tests will use a 0.10 significance level and will be 2-sided unless otherwise noted. Confidence intervals, both individual and simultaneous, will be at 90% confidence level unless stated otherwise.
Case Comprehensive Cancer Center
Other
Clinical Evaluation of PET-MRI Versus PET-CT in Pediatric Oncology Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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