Demonstration Of A Next Generation PET CT System (OMNI dBGO)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oncology
- Sponsor
- GE Healthcare
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Evaluation- Likert Scale
- Last Updated
- 3 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult, who is at least 18 years of age;
- •A clinical indication for PET/CT examination according to current clinical practice standards;
- •Able and willing to provide informed consent for participation in this study
Exclusion Criteria
- •Diabetic patient with a glucose level ≥ 150 mg/dl at the time of the exam (for FDG) or,
- •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,
- •Previously enrolled in this study.
Outcomes
Primary Outcomes
Evaluation- Likert Scale
Time Frame: 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 Outcomes
- Data Collection(through study completion, an average of 1 year)