Demonstration Of A Next Generation PET CT System

Not Applicable

• Conditions: Oncology
• Interventions: Device: Additional PET/CT Scan

• Registration Number: NCT05122715
• Lead Sponsor: GE Healthcare

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-01
• Study Start: 2021-11-09
• Study First Submitted QC: 2021-11-14
• Study First Posted: 2021-11-17
• Status Verified: 2022-02
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-23
• Primary Completion: 2022-07-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMNI PET/CT scan first	Additional PET/CT Scan	-
DMI PET/CT scan first	Additional PET/CT Scan	-

Primary Outcome Measures

Name	Time	Method
Evaluation- Likert Scale	through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Data Collection	through study completion, an average of 1 year	PET/CT Image collection

Trial Locations

Locations (1)

Rambam Healthcare Campus; 🇮🇱 Haifa, Israel