OncologyNCT05122715
Demonstration Of A Next Generation PET CT System
A study testing Additional PET/CT Scan in people with Oncology, run by GE Healthcare at 1 site in Israel.
Trial summary
The intent of this evaluation is to obtain user feedback on device performance, user preference, image quality, workflow, and new device features, a necessary part of product development. This study will also help to inform protocol development in reducing both scan time and/or radiologic tracer dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Additional PET/CT Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Nov 2021to 1 Sep 2022
- Phase
- Interventional
- 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
Who may be able to join
- Adult, who is at least 18 years of age;
- A clinical indication for PET/CT examination according to current clinical practice standards;
- Able and willing to provide informed consent for participation in this study
Who cannot join
- Diabetic patient with a glucose level ≥ 150 mg/dl at the time of the exam (for FDG) or,
- Known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age. No study specific pregnancy test will be performed for this study); or,
- Previously enrolled in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Demonstration Of A Next Generation PET CT System (OMNI dBGO)
The intent of this evaluation is to obtain user feedback on device performance, user preference, image quality, workflow, and new device features, a necessary part of product development. This study will also help to inform protocol development in reducing both scan time and/or radiologic tracer dose. The goal of this study is to collect a library of image data from the hybrid PET/CT system to be used for evaluation and optimization of the image quality of the system in a clinical setting and as comparison with the standard of care hybrid PET/CT system, Discovery MI 25m (DMI5R).
- Conditions
- Oncology
- Being tested
- Additional 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.
Additional PET/CT ScanDevice
The subject will undergo two PET/CT scans, one on the DMI scanner and one on the OMNI scanner.
| Study group | Role | What they receive |
|---|---|---|
| OMNI PET/CT scan first | Other | Not described Receives: Device: Additional PET/CT Scan |
| DMI PET/CT scan first | Other | Not described Receives: Device: Additional PET/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation- Likert Scale
The primary endpoints of this study are completed image evaluation using a 1 point Likert Scale of the OMNI PET/CT system including analysis, reading, and scoring utilizing a Likert Scale, by three (3) qualified Nuclear Medicine physicians.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Data Collection
PET/CT Image collection
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 posted17 Nov 2021
- Study start9 Nov 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian W Thomsen, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122715
- Sponsor's protocol ID
- 215514655
- Status last verified
- Feb 2022
- First submitted
- 1 Nov 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration Of A Next Generation PET CT System (OMNI dBGO)
- ClinicalTrials.gov ID
- NCT05122715
- Acronym / sponsor ID
- 215514655
- Conditions
- Oncology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 17 Nov 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 intent of this evaluation is to obtain user feedback on device performance, user preference, image quality, workflow, and new device features, a necessary part of product development. This study will also help to inform protocol development in reducing both scan time and/or radiologic tracer dose. The goal of this study is to collect a library of image data from the hybrid PET/CT system to be used for evaluation and optimization of the image quality of the system in a clinical setting and as comparison with the standard of care hybrid PET/CT system, Discovery MI 25m (DMI5R).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMNI PET/CT scan first | Other | Device: Additional PET/CT Scan |
| DMI PET/CT scan first | Other | Device: Additional PET/CT Scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult, who is at least 18 years of age;
- A clinical indication for PET/CT examination according to current clinical practice standards;
- Able and willing to provide informed consent for participation in this study
Key exclusion criteria (3 listed)
- Diabetic patient with a glucose level ≥ 150 mg/dl at the time of the exam (for FDG) or,
- Known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age. No study specific pregnancy test will be performed for this study); or,
- Previously enrolled in this study.
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 |
|---|---|---|
| Additional PET/CT ScanThe subject will undergo two PET/CT scans, one on the DMI scanner and one on the OMNI scanner. | Device | DMI PET/CT scan first, OMNI PET/CT scan first |
Primary outcome
Evaluation- Likert Scale
Time frame: through study completion, an average of 1 year
The primary endpoints of this study are completed image evaluation using a 1 point Likert Scale of the OMNI PET/CT system including analysis, reading, and scoring utilizing a Likert Scale, by three (3) qualified Nuclear Medicine physicians.
1 secondary outcome
Data Collection
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- 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?
A study testing Additional PET/CT Scan in people with Oncology, run by GE Healthcare at 1 site in Israel.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 May 2022. 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 Israel. 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?
Results are not available in the source record.
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- Likert Scale (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2022.