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Evaluation of a New Generation of PET-CT OMNI

NCT05154877 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2024-06-07

No results posted yet for this study

Summary

The overarching purpose of the study is to provide supporting evidence to the value proposition of OMNI, that offers global access to an affordable hybrid PET/CT system similar in performance to that of systems utilized by world-class academic centers. Specifically, the study will collect a library of oncology 18FDG PET image data from the OMNI system and evaluate the images as compared to the standard of care PET/CT systems.

This evaluation is being performed as a necessary part of product development in order to obtain user feedback on device performance, user preference, image quality (IQ), workflow, and new device features. This study will also help to inform protocol development in reducing both scan time and radiologic tracer dose.

Conditions

Interventions

DEVICE

OMNI PET/CT Scan

The subject will undergo two PET/CT scans: one on the standard of care scanner and one on the OMNI scanner.

Sponsors & Collaborators

  • Institut Claudius Regaud

    collaborator OTHER

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Brian W Thomsen · GE Healthcare

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2022-08-30
Completion
2023-12-18
FDA Device
Yes

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154877 on ClinicalTrials.gov