Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OMNI PET/CT Scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- DMI5R
- description
- The subject will undergo two PET/CT scans: one on the DMI5R scanner and one on the OMNI scanner.
- interventionNames
- Device: OMNI PET/CT Scan
- label
- DIQ5R
- description
- The subject will undergo two PET/CT scans: one on the DIQ5R scanner and one on the OMNI scanner.
- interventionNames
- Device: OMNI PET/CT Scan
Primary outcomes (2)
- measure
- Evaluation
- timeFrame
- through study completion, an average of 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old; 2. A clinical indication for Fluorodeoxyglucose (FDG or 18F-FDG) PET/CT examination according to current clinical practice standards; 3. Have ≥ 1 WHO Karnofsky index \< 70; 4. Are able to maintain a supine position twice; 5. Are affiliated with a Social Security scheme in France; AND, 6. Are able and willing to provide informed consent for participation in this study, per the EC approved policy. Exclusion Criteria: 1. Have uncontrolled diabetes; 2. Have a formal contraindication to certain imaging examinations (i.e., significant claustrophobia, or other contraindications as determined by the ordering physician.) 3. Are known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age; OR, 4. 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.
References
Publications (1)
- DERIVEDMaronnier 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. PMID 41400899