Demonstration Of A Next Generation PET CT System
1 other identifier
interventional
70
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2021
CompletedStudy Start
First participant enrolled
November 9, 2021
CompletedFirst Posted
Study publicly available on registry
November 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedMay 23, 2022
February 1, 2022
8 months
November 1, 2021
May 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Data Collection
through study completion, an average of 1 year
Study Arms (2)
OMNI PET/CT scan first
OTHERDMI PET/CT scan first
OTHERInterventions
The subject will undergo two PET/CT scans, one on the DMI scanner and one on the OMNI scanner.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GE Healthcarelead
Study Sites (1)
Rambam Healthcare Campus
Haifa, 3109601, Israel
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Brian W Thomsen
GE Healthcare
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2021
First Posted
November 17, 2021
Study Start
November 9, 2021
Primary Completion
July 1, 2022
Study Completion
September 1, 2022
Last Updated
May 23, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share