Evaluation of a New Generation of PET-CT OMNI

Sponsor

GE Healthcare (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05154877

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Oncology	Device: OMNI PET/CT Scan	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: DMI5R The subject will undergo two PET/CT scans, one on the DMI5R scanner and one on the OMNI scanner	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.
Active Comparator: DIQ5R The subject will undergo two PET/CT scans, one on the DIQ5R scanner and one on the OMNI scanner	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.

Arm

Intervention/Treatment

Active Comparator: DMI5R

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

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.

Active Comparator: DIQ5R

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

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.

Outcome Measures

Primary Outcome Measures

Evaluation [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

GE Healthcare

Investigators

Study Director: Stephanie Karwedsky, GE Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GE Healthcare

ClinicalTrials.gov Identifier:

NCT05154877

Other Study ID Numbers:

209658964

First Posted:

Dec 13, 2021

Last Update Posted:

Dec 13, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Dec 13, 2021