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The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Arm PET/MRI | Other | Single-group evaluation of PET/MRI for diagnostic quality of image |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/MRI system | Device | Enrolled subject undergoes PET/MR scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Usable PET/MRI Image Sets | The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale | 1 day |
| Number of Diagnostic Quality Images | Number of images sets deemed diagnostic quality by the investigator | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tibor Duliskovich, Medical Doctor | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UniversitätsSpital Zürich | Zurich | CH-8091 | Switzerland |
Subjects/participants were enrolled in one of three study segments and received a clinically indicated PET/CT exam with radiopharmaceutical injection followed by PET/MRI scanning. Up to two subject datasets (each dataset labelled with unique subject ID) can be collected from one enrolled participant/subject.
First participant enrolled on January 20, 2014. Last participant enrolled on July 07, 2014 at the Zurich University Hospital site. Subject or participant recruitment was prematurely terminated because the sponsor had determined that sufficient data was collected for regulatory submissions
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-Arm PET/MRI | Single-group evaluation of PET/MRI for diagnostic quality of image PET/MRI system: Enrolled subject undergoes PET/MR scan |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-Arm PET/MRI | Single-group evaluation of PET/MRI for diagnostic quality of image PET/MRI system: Enrolled subject undergoes PET/MR scan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Patient/participant must be at least 18 years of age. Eligible subjects were allowed to participate up to two times. |
| 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 | Number Usable PET/MRI Image Sets | The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale | Posted | Number | Usable image sets | 1 day |
|
|
approximately 7 months
subject participants were considered to be actively enrolled from the time the subject entered the scan room for their PET/MR procedure to the time the subject left the PET/MR scan room. AE monitoring were conducted starting from the subject participants signing off the informed consent form until the subject participant left the PET/MR scan room
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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/MRI for diagnostic quality of image PET/MRI system: Enrolled subject undergoes PET/MR scan |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Warming | Musculoskeletal and connective tissue disorders | MedRA | Non-systematic Assessment | the two reported AEs (Warming) were considered to be anticipated, mild, and probably device-related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yvonne Celestial | GE Healthcare | +33625023857 | MarieYvonne.CELESTIAL@ge.com |
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| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
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| Primary | Number of Diagnostic Quality Images | Number of images sets deemed diagnostic quality by the investigator | PET/MR Scans with qualitative comments | Posted | Number | Image sets | 1 day | Number of Image Sets | Number of Image Sets |
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| 0 |
| 62 |
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| 2 |
| 62 |
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