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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00376 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CASE16Z12 | 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 randomized pilot clinical trial studies how well positron emission tomography (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases. PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI is similar to standard-of-care PET-CT, but exposes the patient to less radiation. It is not yet known whether PET-MRI produces better image quality than PET-CT in diagnosing patients with cancer, cardiac disease, or neurologic disease.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET-CT and PET-MRI | Experimental | Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| positron emission tomography | Device | Undergo PET |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Image Quality Scores | 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. | Day 1 |
| Lesion Based Standard Uptake Values (SUV) | 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. | Day 1 |
| Area Under the Receiver Operating Characteristic Curve | 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. | Day 1 |
| Time Effort Associated With the PET-MRI Versus PET-CT With MRI | 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. | Day 1 |
| Radiation Dose Reduction With PET-MRI | 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 | Day 1 |
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Inclusion Criteria:
Clinically indicated PET/PET-CT (with or without clinically indicated diagnostic MRI)
Presenting with one of the four conditions specified below
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Ros, MD, MPH, PhD | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PET-CT and PET-MRI | Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes. positron emission tomography: Undergo PET computed tomography: Undergo CT magnetic resonance imaging: Undergo MRI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| computed tomography | Device | Undergo CT |
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| magnetic resonance imaging | Device | Undergo MRI |
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| COMPLETED |
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| NOT COMPLETED |
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Participants who completed study
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| ID | Title | Description |
|---|---|---|
| BG000 | PET-CT and PET-MRI | Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes. positron emission tomography: Undergo PET computed tomography: Undergo CT magnetic resonance imaging: Undergo 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 | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Overall Image Quality Scores | 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. | No data was obtained from this study group as the patient cohort was inconsistent | Posted | Day 1 |
|
| |||||||||||||||||||
| Primary | Lesion Based Standard Uptake Values (SUV) | 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. | No data was obtained from this study group as the patient cohort was inconsistent | Posted | Day 1 |
|
| |||||||||||||||||||
| Primary | Area Under the Receiver Operating Characteristic Curve | 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. | No data was obtained from this study group as the patient cohort was inconsistent | Posted | Day 1 |
|
| |||||||||||||||||||
| Primary | Time Effort Associated With the PET-MRI Versus PET-CT With MRI | 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. | No data was obtained from this study group as the patient cohort was inconsistent | Posted | Day 1 |
|
| |||||||||||||||||||
| Primary | Radiation Dose Reduction With PET-MRI | 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 | No data was obtained from this study group as the patient cohort was inconsistent | Posted | Day 1 |
|
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At time of scan
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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 | PET-CT and PET-MRI | Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes. positron emission tomography: Undergo PET computed tomography: Undergo CT magnetic resonance imaging: Undergo MRI | 0 | 72 | 0 | 72 |
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No data was obtained from this study group as the patient cohort was inconsistent
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| 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 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003704 | Dementia |
| D005335 | Fever of Unknown Origin |
| D014657 | Vasculitis |
| D010019 | Osteomyelitis |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D005334 | Fever |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D014057 | Tomography, X-Ray Computed |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D011856 | Radiographic Image Enhancement |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
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| Title | Measurements |
|---|---|
|
| 40-49 years |
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| 50-59 years |
|
| 60-69 years |
|
| 70-79 years |
|
| 80-89 years |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|