Evaluation of a New Generation of PET-CT OMNI

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oncology Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Claudius Regaud

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years old;
A clinical indication for Fluorodeoxyglucose (FDG or 18F-FDG) PET/CT examination according to current clinical practice standards;
Have ≥ 1 WHO Karnofsky index < 70;
Are able to maintain a supine position twice;
Are affiliated with a Social Security scheme in France; AND,
Are able and willing to provide informed consent for participation in this study, per the EC approved policy.

Exclusion criteria

Have uncontrolled diabetes;
Have a formal contraindication to certain imaging examinations (i.e., significant claustrophobia, or other contraindications as determined by the ordering physician.)
Are known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age; OR,
Are known to have any psychological, family, geographic, or sociological condition that does not allow compliance with the medical monitoring and/or the procedures provided for in the study protocol.

Treatment and study plan

OMNI PET/CT Scan

Device

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

Primary outcomes

Evaluation

Time frame: through study completion, an average of 1 year

Completed image evaluation will be completed using a 5 point Likert Scale of the OMNI system in comparison to the SoC systems for the same subjects, including analysis, reading, and scoring utilizing Likert Scaling and preference questions by three (3) qualified Nuclear Medicine Physicians. Likert scale is 1-5, 3,4 & 5 being of diagnostic quality.
Lesion Detectability

Time frame: through study completion, an average of 1 year
Three (3) qualified Nuclear Medicine Physicians shall complete a lesion detectability evaluation of the SoC PET/CT scan (as determined in Phase 1) and OMNI PET/CT scan for each lesion identified for each subject.

Each reader will evaluate the reconstructed images by qualitatively evaluating the visibility of the lesions and by measuring the relevant quantitative values of glycolytic activity of each suspicious lesion (contrast, noise, SUV). The variables conventionally used to quantify the glycolytic activity in PET for characterization, prognosis and therapeutic monitoring are as follows:
- SUV (Standardized Uptake Value): SUVmax, SUVmean, SUVpeak
- Metabolically active volume: VMA
- Total glycolysis of the lesion: TLG = SUV x VMA The reader shall provide the location information of each identified lesion.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

Institut Claudius Regaud

Registry information

Official study title

Evaluation of the Quality of Images and the Sensitivity of Detection of Sub-Centimeter Lesions of a New Generation of PET-CT OMNI

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Dec 13, 2021
Registry last updated: Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed