PET/MRI and PET/CT in Diagnosing Younger Patients With Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of PET-MRI Versus PET-CT in Pediatric Oncology Patients

Conditions
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Childhood Cancer

Intervention / Treatment
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* Radiation: fludeoxyglucose F 18
* Procedure: positron emission tomography
* Procedure: computed tomography
* Procedure: positron emission tomography
* Procedure: magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are referred by their physician for clinically indicated diagnostic fludeoxyglucose F 18 (18F-FDG) PET/CT (with or without clinically indicated diagnostic MRI) Subjects with malignancies including hematologic disorders Subjects NOT requiring sedation or anesthesia Stable physical medical conditions (patients conscious and comfortable, scheduled for an elective diagnostic imaging) Exclusion Criteria: Subjects who are unable or unwilling to give their assent to both examinations if > 7 years old Subjects requiring general anesthesia or sedation in order to undergo PET/CT or MRI Subjects unable to undergo magnetic resonance (MR) scanning due to exclusion by University Hospitals-Case Medical Center restriction policies for Magnetic Resonance Imaging (UHCMC MRI restriction policies) as mentioned in the standard UHCMC MRI informed consent form Previously known allergies against MRI contrast agents (exclusion criterion only for contrast enhanced MRI) Pregnant or breast feeding subjects, as determined by standard questionnaire administered prior to scanning

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI)<br>Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI. | Radiation: fludeoxyglucose F 18<br>* Undergo fludeoxyglucose F 18 PET/CT<br>* Other names: FDG;Procedure: positron emission tomography<br>* Undergo fludeoxyglucose F 18 PET/CT<br>* Other names: tomography, emission computed;Procedure: computed tomography<br>* Undergo fludeoxyglucose F 18 PET/CT<br>* Other names: tomography, computed;Procedure: positron emission tomography<br>* Undergo PET/MRI<br>* Other names: tomography, emission computed;Procedure: magnetic resonance imaging<br>* Undergo PET/MRI<br>* Other names: nuclear magnetic resonance imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy of PET/MRI | 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. | 1 day | 
| Diagnostic Accuracy of PET/CT | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVs Using PET/MRI | 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. | 1 day | 
| SUVs Using PET/CT | 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. | 1 day | 
| Radiation Dose Reduction Associated With PET/MRI | 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. | 1 day | 
| Time Effort Associated With the PET/MRI | 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. | 1 day |