OncologyNCT05154877
Evaluation of a New Generation of PET-CT OMNI
An observational study of Oncology, run by GE Healthcare at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- OMNI PET/CT Scan
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2022to 18 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Quality of Images and the Sensitivity of Detection of Sub-Centimeter Lesions of a New Generation of PET-CT OMNI
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
- Oncology
- Being tested
- OMNI PET/CT Scan
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNI PET/CT ScanDevice
The subject will undergo two PET/CT scans: one on the standard of care scanner and one on the OMNI scanner.
| Study group | Role | What they receive |
|---|---|---|
| DMI5R | The subject will undergo two PET/CT scans: one on the DMI5R scanner and one on the OMNI scanner. Receives: Device: OMNI PET/CT Scan | |
| DIQ5R | The subject will undergo two PET/CT scans: one on the DIQ5R scanner and one on the OMNI scanner. Receives: Device: OMNI PET/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start30 May 2022
- Primary completion30 Aug 2022
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Claudius Regaud
- Responsible party
- Sponsor
- Investigators
- Brian W Thomsen, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154877
- Sponsor's protocol ID
- 209658964
- Status last verified
- Jun 2024
- First submitted
- 1 Nov 2021
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41400899
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Images and the Sensitivity of Detection of Sub-Centimeter Lesions of a New Generation of PET-CT OMNI
- ClinicalTrials.gov ID
- NCT05154877
- Acronym / sponsor ID
- 209658964
- Conditions
- Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Institut Claudius Regaud
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMI5R | – | Device: OMNI PET/CT ScanThe subject will undergo two PET/CT scans: one on the DMI5R scanner and one on the OMNI scanner. |
| DIQ5R | – | Device: OMNI PET/CT ScanThe subject will undergo two PET/CT scans: one on the DIQ5R scanner and one on the OMNI scanner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMNI PET/CT ScanThe subject will undergo two PET/CT scans: one on the standard of care scanner and one on the OMNI scanner. | Device | DIQ5R, DMI5R |
Primary outcome
Evaluation
Time frame: through study completion, an average of 1 year
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.
Lesion Detectability
Time frame: through study completion, an average of 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 41400899Maronnier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian W Thomsen study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by GE Healthcare at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05154877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.