Evaluation of a New Generation of PET-CT OMNI

General Electric (GE)

Status: Completed

Conditions: Oncology

Treatments: Device: OMNI PET/CT Scan

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05154877

209658964

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Have uncontrolled diabetes;
2. Have a formal contraindication to certain imaging examinations (i.e., significant claustrophobia, or other contraindications as determined by the ordering physician.)
3. Are known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age; OR,
4. 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.

Trial design

45 participants in 2 patient groups

DMI5R

Description:

The subject will undergo two PET/CT scans: one on the DMI5R scanner and one on the OMNI scanner.

Treatment:

Device: OMNI PET/CT Scan

DIQ5R

Description:

The subject will undergo two PET/CT scans: one on the DIQ5R scanner and one on the OMNI scanner.

Treatment:

Device: OMNI PET/CT Scan