An observational study in Oncology, sponsored by GE Healthcare. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by GE Healthcare · Observational
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 45 is below the median of 202 across 1,742 observational studies indexed under Neoplasms.
Browse Neoplasms studies →GE Healthcare is the lead sponsor of 175 studies on the registry; 20 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
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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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Exclusion Criteria:
The subject will undergo two PET/CT scans: one on the DMI5R scanner and one on the OMNI scanner.
Device: OMNI PET/CT Scan
The subject will undergo two PET/CT scans: one on the DIQ5R scanner and one on the OMNI scanner.
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.
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.
Time frame: 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: * SUV (Standardized Uptake Value): SUVmax, SUVmean, SUVpeak * Metabolically active volume: VMA * Total glycolysis of the lesion: TLG = SUV x VMA The reader shall provide the location information of each identified lesion.
Time frame: through study completion, an average of 1 year
Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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