Demonstration Of A Next Generation PET CT System

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05122715

Enrollment

Registered

2021-11-17

Start date

2021-11-09

Completion date

2022-09-01

Last updated

2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncology

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).

Interventions

DEVICEAdditional PET/CT Scan

The subject will undergo two PET/CT scans, one on the DMI scanner and one on the OMNI scanner.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026