Demonstration Of A Next Generation PET CT System

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05122715
• Other study ID #: 215514655
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2022
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

Device:
• Additional PET/CT Scan
The subject will undergo two PET/CT scans, one on the DMI scanner and one on the OMNI scanner.

Locations

Country	Name	City	State
Israel	Rambam Healthcare Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

Israel, 

Outcome

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