Demonstration Of A Next Generation PET CT System

Demonstration Of A Next Generation PET CT System (OMNI dBGO)

The intent of this evaluation is to obtain user feedback on device performance, user preference, image quality, workflow, and new device features, a necessary part of product development. This study will also help to inform protocol development in reducing both scan time and/or radiologic tracer dose. The goal of this study is to collect a library of image data from the hybrid PET/CT system to be used for evaluation and optimization of the image quality of the system in a clinical setting and as comparison with the standard of care hybrid PET/CT system, Discovery MI 25m (DMI5R).

Study Overview

• Status: Active, not recruiting
• Conditions: Oncology
• Intervention / Treatment: Device: Additional PET/CT Scan

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Rambam Healthcare Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult, who is at least 18 years of age;
2. A clinical indication for PET/CT examination according to current clinical practice standards;
3. Able and willing to provide informed consent for participation in this study

Exclusion Criteria:

1. Diabetic patient with a glucose level ≥ 150 mg/dl at the time of the exam (for FDG) or,
2. Known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age. No study specific pregnancy test will be performed for this study); or,
3. Previously enrolled in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: OMNI PET/CT scan first	Device: Additional PET/CT Scan; The subject will undergo two PET/CT scans, one on the DMI scanner and one on the OMNI scanner.
Other: DMI PET/CT scan first	Device: Additional PET/CT Scan; The subject will undergo two PET/CT scans, one on the DMI scanner and one on the OMNI scanner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation- Likert Scale	The primary endpoints of this study are completed image evaluation using a 1 point Likert Scale of the OMNI PET/CT system including analysis, reading, and scoring utilizing a Likert Scale, by three (3) qualified Nuclear Medicine physicians.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data Collection	PET/CT Image collection	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Study Director: Brian W Thomsen, GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 14, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 215514655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes