EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET (EQUIP)

April 6, 2026 updated by: Peter MacCallum Cancer Centre, Australia

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult, who is at least 18 years of age
  2. 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
  3. Able and willing to provide informed consent for participation in this study

Exclusion Criteria:

1) Known to be pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imaging on Total Body PET
Participants in this arm undergo a total body PET scan after conventional standard-of-care imaging
Device: PET
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare diagnostic image quality on the Omni TB with an existing PET/CT device
Time Frame: 1 Day
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.
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
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.
1 Day
To compare the noise characteristics of images acquired using the Omni TB with an existing PET/CT device
Time Frame: 1 Day
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
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
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
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
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
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
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
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 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
1 Day
To evaluate the quality of images obtained by the Omni TB with reduced scan time
Time Frame: 1 Day
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
1 Day
To evaluate the quality of images obtained by the Omni TB with reduced injected radioactivity
Time Frame: 1 Day
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
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter MacCallum Cancer Centre, Australia

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Michael Hofman, Prof, Peter MacCallum Cancer Centre, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2025

Primary Completion (Estimated)

December 24, 2026

Study Completion (Estimated)

December 24, 2026

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Actual)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMC121005 (25/150)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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