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Demonstration Of A Next Generation PET CT System

Sponsor
GE Healthcare (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05122715
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
9.7
Anticipated Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Additional PET/CT Scan
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Demonstration Of A Next Generation PET CT System (OMNI dBGO)
Actual Study Start Date :
Nov 9, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: OMNI PET/CT scan first

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Data Collection [through study completion, an average of 1 year]

    PET/CT Image collection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rambam Healthcare Campus Haifa Israel 3109601

Sponsors and Collaborators

  • GE Healthcare

Investigators

  • Study Director: Brian W Thomsen, GE Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT05122715
Other Study ID Numbers:
  • 215514655
First Posted:
Nov 17, 2021
Last Update Posted:
May 23, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of May 23, 2022