Evaluation of a New Generation of PET-CT OMNI

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Quality of Images and the Sensitivity of Detection of Sub-Centimeter Lesions of a New Generation of PET-CT OMNI

Conditions
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Oncology

Intervention / Treatment
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* Device: OMNI PET/CT Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old; A clinical indication for Fluorodeoxyglucose (FDG or 18F-FDG) PET/CT examination according to current clinical practice standards; Have ≥ 1 WHO Karnofsky index < 70; Are able to maintain a supine position twice; Are affiliated with a Social Security scheme in France; AND, Are able and willing to provide informed consent for participation in this study, per the EC approved policy. Exclusion Criteria: Have uncontrolled diabetes; Have a formal contraindication to certain imaging examinations (i.e., significant claustrophobia, or other contraindications as determined by the ordering physician.) Are known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age; OR, Are known to have any psychological, family, geographic, or sociological condition that does not allow compliance with the medical monitoring and/or the procedures provided for in the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DMI5R<br>The DMI5R scanner is the standard of care PET/CT for this arm. | Device: OMNI PET/CT Scan<br>* The subject will undergo two PET/CT scans: one on the standard of care scanner and one on the OMNI scanner.<br>|
| Other: DIQ5R<br>The DIQ5R scanner is the standard of care PET/CT for this arm. | Device: OMNI PET/CT Scan<br>* The subject will undergo two PET/CT scans: one on the standard of care scanner and one on the OMNI scanner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: 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. | through study completion, an average of 1 year |