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The objective of this study is to gather image and associated data to of a pre-market PET/MRI scanner and to use the data for regulatory submission and future product development and marketing. Clinical data is required in order to test the MR attenuation correction of PET data. These aims can only be accomplished through a clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm PET MRI | Other | single group evaluation of PET/MRI system scan for diagnostic quality of image |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/MRI system | Device | Compared to PET CT |
|
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| Measure | Description | Time Frame |
|---|---|---|
| PET/MR Images Clinical Usefulness | Clinically relevant images are obtained | 1 day |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Roee Lazebnik, MD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - San Francisco | San Francisco | California | 94143 | United States | ||
| Stanford University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm PET MRI | single group evaluation of PET/ MR for diagnostic quality of image PET/MRI system: Compared to PET CT |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intent to treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm PET MRI | single group evaluation of PET/ MR for diagnostic quality of image PET/MRI system: Compared to PET CT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | PET/MR Images Clinical Usefulness | Clinically relevant images are obtained | Subjects with images successfully collected using PET/ MR | Posted | Number | Participants | 1 day |
|
|
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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 | Single Arm PET MRI | single group evaluation of PET/ MR for diagnostic quality of image PET/MRI system: Compared to PET CT |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Localized Warming | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terri Hanlon, Clinical Affairs Project Manager | GE Healthcare | 609-578-0173 | terri.hanlon@GE.com |
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| Stanford |
| California |
| 94305 |
| United States |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
|
| 0 |
| 58 |
| 5 |
| 58 |
| Unilateral superficial skin injury of ear from head coil placement | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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