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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00169 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Funding unavailable
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to treatment
PRIMARY OBJECTIVES:
I. To acquire PET/MRI scans of 100 patients which will be compared with PET/CT scans of the same subjects. The PET/CT scans will be used to provide the gold standard for evaluating the image quality and quantitative performance of the PET/MRI scans. After comparison and evaluation of the imaging capabilities and performance of the sequential PET/MRI imaging system for these 100 subjects, a second cohort of hundred consecutive subjects may be necessary and again comparisons made to the current standard of PET imaging, PET/CT. This validation of the attenuation correction methods and quantitative accuracy of the PET/MRI device compared to PET/CT will be a continuous iterative process that will result in optimized performance of the PET/MRI and will be a key step in its becoming available to other clinical research projects both within the Seidman Cancer Center as well as in other institutions.
OUTLINE:
After undergoing standard PET/CT, patients undergo PET/MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (PET/MRI) | Experimental | After undergoing standard PET/CT, patients undergo PET/MRI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic resonance imaging with positron emission tomography scanning | Device | University Hospitals Seidman Cancer Center [SCC] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status. |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI | SUVs for various normal tissues such as liver, cardiac blood pool, and bone will be used. Selected lesions will be assessed as well. Maximum and mean SUVs will be measured for each imaging device. The SUVs and tumor/background ratios will be measured. | After PET/MRI |
| Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc. | A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test. | After PET/MRI |
| Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc. | A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test. | After PET/MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Faulhaber | University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (PET/MRI) | After undergoing standard PET/CT, patients undergo PET/MRI. magnetic resonance imaging with positron emission tomography scanning: University Hospitals Seidman Cancer Center [SCC] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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All participants completing study
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (PET/MRI) | After undergoing standard PET/CT, patients undergo PET/MRI. magnetic resonance imaging with positron emission tomography scanning: University Hospitals Seidman Cancer Center [SCC] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI | SUVs for various normal tissues such as liver, cardiac blood pool, and bone will be used. Selected lesions will be assessed as well. Maximum and mean SUVs will be measured for each imaging device. The SUVs and tumor/background ratios will be measured. | Not available because SUV data not collected. | Posted | After PET/MRI |
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| Primary | Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc. | A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test. | Not available because data not collected. | Posted | After PET/MRI |
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| Primary | Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc. | A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test. | Not available because data not collected. | Posted | After PET/MRI |
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At time of scan. No more than 24 hours.
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 (PET/MRI) | After undergoing standard PET/CT, patients undergo PET/MRI. magnetic resonance imaging with positron emission tomography scanning: University Hospitals Seidman Cancer Center [SCC] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status. | 0 | 98 | 0 | 98 |
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Outcome data not collected.
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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 |
|---|---|
| D003110 | Colonic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007090 | Image Interpretation, Computer-Assisted |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |
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| Title | Measurements |
|---|---|
|
| 50-59 years |
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| 60-69 years |
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| 70-79 years |
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| 80-89 years |
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| 90-99 |
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| Unknown |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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