CancerEQUIPNCT07263815
EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET
A study testing PET in people with Cancer, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial summary
The GE Healthcare Omni Total Body (TB) 128cms (Omni TB) is a long-axial field-of-view (LAFOV) PET/CT scanner and will be installed in a pre-market phase at the Peter MacCallum Cancer Centre. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PET
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Nov 2025to 24 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Referred for a clinically indicated PET/CT scan with radiotracers F-18 FDG, F-18 DCFPyL, Ga-68 PSMA, Ga-68 DOTATATE or I-124
- Able and willing to provide informed consent for participation in this study
Who cannot join
- 1) Known to be pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
The GE Healthcare Omni Total Body (TB) 128cms (Omni TB) is a long-axial field-of-view (LAFOV) PET/CT scanner and will be installed in a pre-market phase at the Peter MacCallum Cancer Centre.
The main features and functionality of this new scanner include high sensitivity, high resolution digital detectors based on silicon photomultipliers. The ultra-high sensitivity and extended field of view are designed to support the ability to reduce administrated dose and/or shorten acquisition time without compromising the image quality of the PET imaging.
Read more
To verify the appearance of images acquired on the Omni TB with images acquired on our conventional PET/CT equipment, a study imaging a cohort of patients on both devices is proposed. The study involves no additional radiopharmaceutical administration.
Additionally, in keeping with ALARA (as low as reasonably achievable) radiation dose practices, it will be possible to model acquisition settings (duration, administered activity and reconstruction parameters) using the system raw data and a suite of research tools to optimise acquisition parameters.
- Conditions
- Cancer
- Being tested
- PET
- Keywords
- Total Body PET, EQUIP, Diagnostic, Imaging
- Medical subject headings
- Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETDevice
This device images the whole body simultaneously with greater sensitivity allowing imaging to occur faster and with less radiation dose compared to conventional PET systems
| Study group | Role | What they receive |
|---|---|---|
| Imaging on Total Body PET | Experimental | Participants in this arm undergo a total body PET scan after conventional standard-of-care imaging Receives: Device: PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the diagnostic quality of images acquired on the OMNI 128 Total Body PET
To analyse the diagnostic image quality visually on the Omni TB with radiotracers F-18 FDG, F-18 DCFPyL, Ga-68 PSMA, Ga-68 DOTATATE or I-124
Measured: 1 Day
Secondary outcomes (9)
To compare diagnostic image quality on the Omni TB with an existing PET/CT device
Three nuclear medicine specialists will qualitatively assess diagnostic image quality using the the 5-point Likert visual grading score. Reviewers will be blinded to the clinical indication, camera model and reconstruction parameters prior to scoring to remove potential bias by expert reviewers.
Measured: 1 Day
To compare the sharpness and conspicuity of images produced on the Omni TB with an existing PET/CT device
Three nuclear medicine specialists will qualitatively assess the sharpness and conspicuity of images using the the 5-point Likert visual grading score. Reviewers will be blinded to the clinical indication, camera model and reconstruction parameters prior to scoring to remove potential bias by expert reviewers.
Measured: 1 Day
To compare the noise characteristics of images acquired using the Omni TB with an existing PET/CT device
Three nuclear medicine specialists will qualitatively assess the noise characteristics of images using the the 5-point Likert visual grading score. Reviewers will be blinded to the clinical indication, camera model and reconstruction parameters prior to scoring to remove potential bias by expert reviewers
Measured: 1 Day
To compare the quantitative parameters of SUVmean and SUVmax in normal organs on the Omni TB with an existing PET/CT device
One nuclear medicine physician will create a region of interest (ROI) around seven normal tissues (kidneys, liver, spleen, muscle, brain, blood pool, and normal lung) to calculate the SUVmean and SUVmax. This assessment will be conducted on all images acquired to allow a comparison between imaging systems
Measured: 1 Day
To quantitatively compare the noise characteristics (signal to noise) of images acquired using the Omni TB with an existing PET/CT device
The signal to noise ratio (SNR) will be determined by selecting a volume-of-interest (14cm3) in a region of normal liver. The standard deviation and mean of SUV values within this area will be calculated and used to determine the coefficient of variance (COV) by dividing the SUV standard deviation by the SUVmean. The SNR will then be calculated as the reciprocal of the COV
Measured: 1 Day
To compare the quantitative parameters of SUVmean, SUVmax and SUVpeak in up to three candidate lesions visualised on the Omni TB and an existing PET/CT device
One nuclear medicine physician will create a spherical 2 cm region of interest (ROI) around up to three candidate lesions to calculate the SUVmean and SUVmax. Target lesion uptake will be determined by placing a 40% isocontour volume of interest (VOI) around the lesion and calculating SUVpeak. This assessment will be conducted on all images acquired to allow a comparison between imaging devices
Measured: 1 Day
To compare the visibility of lesions in images acquired using the Omni TB with images acquired on an existing PET/CT device
To quantify the contrast between lesions and surrounding normal tissue the tumour to background ratio will be calculated as a function of the lesion SUVpeak over the SUV in the background. These values will be compared across imaging devices
Measured: 1 Day
To evaluate the quality of images obtained by the Omni TB with reduced scan time
Patients imaged using the Omni TB system will have their images acquired for 10 minutes using LIST mode. This raw list mode data will be retrospectively reconstructed so only data over a specified time frame can be evaluated. Time frames will include, 10, 5, 2 and 1 min. These reconstructions will be analysed according to the secondary outcome measures 2 to 8
Measured: 1 Day
To evaluate the quality of images obtained by the Omni TB with reduced injected radioactivity
Patients imaged using the Omni TB system will have their images acquired for 10 minutes using LIST mode. This raw list mode data will be retrospectively reconstructed to match the time per bed step used for the conventional PET/CT device. To simulate a lowered injection dose the LIST mode data will undergo Poisson resampling using the following factors, 1/2, 1/4, 1/8, 1/16
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start24 Nov 2025
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Michael Hofman, Prof, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263815
- Sponsor's protocol ID
- PMC121005 (25/150)
- Acronym
- EQUIP
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET
- ClinicalTrials.gov ID
- NCT07263815
- Acronym / sponsor ID
- EQUIP / PMC121005 (25/150)
- Conditions
- Cancer
- Keywords
- Total Body PET, EQUIP, Diagnostic, Imaging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 4 Dec 2025 (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 GE Healthcare Omni Total Body (TB) 128cms (Omni TB) is a long-axial field-of-view (LAFOV) PET/CT scanner and will be installed in a pre-market phase at the Peter MacCallum Cancer Centre.
The main features and functionality of this new scanner include high sensitivity, high resolution digital detectors based on silicon photomultipliers. The ultra-high sensitivity and extended field of view are designed to support the ability to reduce administrated dose and/or shorten acquisition time without compromising the image quality of the PET imaging.
To verify the appearance of images acquired on the Omni TB with images acquired on our conventional PET/CT equipment, a study imaging a cohort of patients on both devices is proposed. The study involves no additional radiopharmaceutical administration.
Additionally, in keeping with ALARA (as low as reasonably achievable) radiation dose practices, it will be possible to model acquisition settings (duration, administered activity and reconstruction parameters) using the system raw data and a suite of research tools to optimise acquisition parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging on Total Body PET | Experimental | Device: PETParticipants in this arm undergo a total body PET scan after conventional standard-of-care imaging |
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
- Referred for a clinically indicated PET/CT scan with radiotracers F-18 FDG, F-18 DCFPyL, Ga-68 PSMA, Ga-68 DOTATATE or I-124
- Able and willing to provide informed consent for participation in this study
Key exclusion criteria (1 listed)
- 1) Known to be pregnant or breastfeeding
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 |
|---|---|---|
| PETThis device images the whole body simultaneously with greater sensitivity allowing imaging to occur faster and with less radiation dose compared to conventional PET systems | Device | Imaging on Total Body PET |
Primary outcome
To assess the diagnostic quality of images acquired on the OMNI 128 Total Body PET
Time frame: 1 Day
To analyse the diagnostic image quality visually on the Omni TB with radiotracers F-18 FDG, F-18 DCFPyL, Ga-68 PSMA, Ga-68 DOTATATE or I-124
9 secondary outcomes
To compare diagnostic image quality on the Omni TB with an existing PET/CT device
Time frame: 1 Day
To compare the sharpness and conspicuity of images produced on the Omni TB with an existing PET/CT device
Time frame: 1 Day
To compare the noise characteristics of images acquired using the Omni TB with an existing PET/CT device
Time frame: 1 Day
To compare the quantitative parameters of SUVmean and SUVmax in normal organs on the Omni TB with an existing PET/CT device
Time frame: 1 Day
To quantitatively compare the noise characteristics (signal to noise) of images acquired using the Omni TB with an existing PET/CT device
Time frame: 1 Day
To compare the quantitative parameters of SUVmean, SUVmax and SUVpeak in up to three candidate lesions visualised on the Omni TB and an existing PET/CT device
Time frame: 1 Day
To compare the visibility of lesions in images acquired using the Omni TB with images acquired on an existing PET/CT device
Time frame: 1 Day
To evaluate the quality of images obtained by the Omni TB with reduced scan time
Time frame: 1 Day
To evaluate the quality of images obtained by the Omni TB with reduced injected radioactivity
Time frame: 1 Day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- 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.
Michael Hofman, Prof principal investigator
Peter MacCallum Cancer Centre, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET in people with Cancer, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
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?
To assess the diagnostic quality of images acquired on the OMNI 128 Total Body PET (time frame: 1 Day). 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 8 Apr 2026.