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Clinical Trials/NCT07263815
NCT07263815Active, not recruitingNot Applicable

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

Peter MacCallum Cancer Centre, Australia2 sites in 1 country25 target enrollmentStarted: November 24, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
25
Locations
2
Primary Endpoint
To assess the diagnostic quality of images acquired on the OMNI 128 Total Body PET

Study Overview

Brief 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.

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

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 1) Known to be pregnant or breastfeeding

Arms & Interventions

Imaging on Total Body PET

Experimental

Participants in this arm undergo a total body PET scan after conventional standard-of-care imaging

Intervention: PET (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • To compare diagnostic image quality on the Omni TB with an existing PET/CT device(1 Day)
  • To compare the sharpness and conspicuity of images produced on the Omni TB with an existing PET/CT device(1 Day)
  • To compare the noise characteristics of images acquired using the Omni TB with an existing PET/CT device(1 Day)
  • To compare the quantitative parameters of SUVmean and SUVmax in normal organs on the Omni TB with an existing PET/CT device(1 Day)
  • To quantitatively compare the noise characteristics (signal to noise) of images acquired using the Omni TB with an existing PET/CT device(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(1 Day)
  • To evaluate the quality of images obtained by the Omni TB with reduced injected radioactivity(1 Day)
  • To compare the visibility of lesions in images acquired using the Omni TB with images acquired on an existing PET/CT device(1 Day)
  • To evaluate the quality of images obtained by the Omni TB with reduced scan time(1 Day)

Investigators

Sponsor
Peter MacCallum Cancer Centre, Australia
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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