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| Name | Class |
|---|---|
| Institut Claudius Regaud | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMI5R | The subject will undergo two PET/CT scans: one on the DMI5R scanner and one on the OMNI scanner. |
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| DIQ5R | The subject will undergo two PET/CT scans: one on the DIQ5R scanner and one on the OMNI scanner. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMNI PET/CT Scan | Device | The subject will undergo two PET/CT scans: one on the standard of care scanner and one on the OMNI scanner. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation | Completed image evaluation will be completed using a 5 point Likert Scale of the OMNI system in comparison to the SoC systems for the same subjects, including analysis, reading, and scoring utilizing Likert Scaling and preference questions by three (3) qualified Nuclear Medicine Physicians. Likert scale is 1-5, 3,4 & 5 being of diagnostic quality. | through study completion, an average of 1 year |
| Lesion Detectability | Three (3) qualified Nuclear Medicine Physicians shall complete a lesion detectability evaluation of the SoC PET/CT scan (as determined in Phase 1) and OMNI PET/CT scan for each lesion identified for each subject. Each reader will evaluate the reconstructed images by qualitatively evaluating the visibility of the lesions and by measuring the relevant quantitative values of glycolytic activity of each suspicious lesion (contrast, noise, SUV). The variables conventionally used to quantify the glycolytic activity in PET for characterization, prognosis and therapeutic monitoring are as follows:
| through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects having an indication for FDG or 18F-FDG PET/CT examination according to current clinical practice standards will be enrolled in this study. These subjects are representative of the general population that is expected to use the device in clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Brian W Thomsen | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Claudius Regaud | Toulouse | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41400899 | Derived | Maronnier Q, Cassou-Mounat T, Gabiache E, Latge A, Terroir M, Vija L, Su KH, Caselles O, Courbon F. Deep learning-enhanced digital-BGO versus TOF PET/CT: comparative assessment of detection, quantitation, and overall image quality. EJNMMI Phys. 2025 Dec 16;13(1):4. doi: 10.1186/s40658-025-00814-8. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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