Trials / Completed
CompletedNCT05154877
Evaluation of a New Generation of PET-CT OMNI
Evaluation of the Quality of Images and the Sensitivity of Detection of Sub-Centimeter Lesions of a New Generation of PET-CT OMNI
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 45 (actual)
- Sponsor
- GE Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The overarching purpose of the study is to provide supporting evidence to the value proposition of OMNI, that offers global access to an affordable hybrid PET/CT system similar in performance to that of systems utilized by world-class academic centers. Specifically, the study will collect a library of oncology 18FDG PET image data from the OMNI system and evaluate the images as compared to the standard of care PET/CT systems. This evaluation is being performed as a necessary part of product development in order to obtain user feedback on device performance, user preference, image quality (IQ), workflow, and new device features. This study will also help to inform protocol development in reducing both scan time and radiologic tracer dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OMNI PET/CT Scan | The subject will undergo two PET/CT scans: one on the standard of care scanner and one on the OMNI scanner. |
Timeline
- Start date
- 2022-05-30
- Primary completion
- 2022-08-30
- Completion
- 2023-12-18
- First posted
- 2021-12-13
- Last updated
- 2024-06-07
Locations
1 site across 1 country: France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05154877. Inclusion in this directory is not an endorsement.