NCT07263815

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable cancer

Timeline
8mo left

Started Nov 2025

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Nov 2025Dec 2026

First Submitted

Initial submission to the registry

November 13, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

November 24, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2026

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

November 13, 2025

Last Update Submit

April 6, 2026

Conditions

Cancer

Keywords

Total Body PETEQUIPDiagnosticImaging

Outcome Measures

Primary Outcomes (1)

  • 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

    1 Day

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

Imaging on Total Body PET

EXPERIMENTAL

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

Device: PET

Interventions

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

Imaging on Total Body PET

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \) Known to be pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

MeSH Terms

Conditions

NeoplasmsDisease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Hofman, Prof

    Peter MacCallum Cancer Centre, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

December 4, 2025

Study Start

November 24, 2025

Primary Completion (Estimated)

December 24, 2026

Study Completion (Estimated)

December 24, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)