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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00828 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CASE1Z13 | |||
| CASE 1Z13 | Other Identifier | Case Comprehensive Cancer Center | |
| P30CA043703 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI) | Experimental | Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fludeoxyglucose F 18 | Radiation | Undergo fludeoxyglucose F 18 PET/CT |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Bangert | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (Fludeoxyglucose F 18 PET/CT and PET/MRI) | Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI. fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT computed tomography: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo PET/MRI magnetic resonance imaging: Undergo PET/MRI |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Fludeoxyglucose F 18 PET/CT and PET/MRI) | Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI. fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT computed tomography: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo PET/MRI magnetic resonance imaging: Undergo PET/MRI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible. | Posted | 1 day |
|
At time of scan
No adverse events were documented for this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (Fludeoxyglucose F 18 PET/CT and PET/MRI) | Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI. fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT computed tomography: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo PET/MRI magnetic resonance imaging: Undergo PET/MRI |
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Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philipp Frank Graner | Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | +1 216-844-8275 | philipp.graner@uhhospitals.org |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
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| positron emission tomography | Procedure | Undergo fludeoxyglucose F 18 PET/CT |
|
|
| computed tomography | Procedure | Undergo fludeoxyglucose F 18 PET/CT |
|
|
| positron emission tomography | Procedure | Undergo PET/MRI |
|
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| magnetic resonance imaging | Procedure | Undergo PET/MRI |
|
|
| 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 |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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. | Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible. | Posted | 1 day |
|
|
| Secondary | 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. | Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible. | Posted | 1 day |
|
|
| Secondary | 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. | Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible. | Posted | 1 day |
|
|
| Secondary | 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. | Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible. | Posted | 1 day |
|
|
| Secondary | 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. | Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible. | Posted | 1 day |
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| 0 |
| 13 |
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| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |