Evaluation of a New Generation of PET-CT OMNI

NCT05154877 | Completed FDA Device

• 1 other identifier: 209658964
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology

Outcome Measures

Primary Outcomes (2)

• Evaluation

  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.

  through study completion, an average of 1 year

• Lesion Detectability

  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.

  through study completion, an average of 1 year

Study Arms (2)

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

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

Interventions

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.

DIQ5R; DMI5R

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects having an indication for FDG or 18F-FDG PET/CT examination according to current clinical practice standards will be enrolled in this study. These subjects are representative of the general population that is expected to use the device in clinical practice.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• Institut Claudius Regaud: collaborator

Study Sites (1)

Institut Claudius Regaud

Toulouse, France

Location

Related Publications (1)

• Maronnier Q, Cassou-Mounat T, Gabiache E, Latge A, Terroir M, Vija L, Su KH, Caselles O, Courbon F. Deep learning-enhanced digital-BGO versus TOF PET/CT: comparative assessment of detection, quantitation, and overall image quality. EJNMMI Phys. 2025 Dec 16. doi: 10.1186/s40658-025-00814-8. Online ahead of print.

  PMID: 41400899 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Brian W Thomsen

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: December 13, 2021
• Study Start: May 30, 2022
• Primary Completion: August 30, 2022
• Study Completion: December 18, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)