Positron Emission Tomography/Computed Tomography (PECT/CT) Double-Scanning Study
Evaluation of Advancements in PET/CT Imaging
This study aims to collect clinical image data using the Omni 128 cm PET/CT system and compare image quality and performance with clinically indicated PET/CT examinations. Adult participants undergoing a clinically indicated PET/CT scan will also undergo imaging on the Omni 128 cm PET/CT system for research evaluation purposes.
Study Overview
Detailed Description
This study is evaluating a new PET/CT imaging system, Omni 128 cm PET/CT. Adults undergoing a clinically indicated PET/CT scan will also receive an additional research scan on the Omni system. Researchers will compare the images and collect imaging data to help assess the performance of the new technology. The information gathered may be used to support regulatory submissions, improve future PET/CT systems, and advance medical imaging research. Participation involves a single study visit and no follow-up is required.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Erin Terrell, MS
- Phone Number: 262-449-3363
- Email: erin.terrell@gehealthcare.com
Study Locations
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California
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Stanford, California, United States, 94305
- Recruiting
- Stanford University
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Principal Investigator:
- Andrei Iagaru, MD
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Contact:
- Andrea Otte, DPT, CCRC
- Phone Number: 650-736-4183
- Email: anotte@stanford.edu
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Sub-Investigator:
- Erin Grady, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Participants who have a clinically indicated PET/CT examination according to current clinical practice standards and according to the data required for the study will be enrolled in this study.
Description
Inclusion Criteria:
- Must have a clinical indicated PET/CT exam scheduled including (but not limited to) one of the following radiopharmaceutical tracers: Fluorodeoxyglucose (FDG or 18F-FDG), 18F-DCFPyL; 68Ga- PSMA; 68Ga Dotatate; 18F Amyloid (18F- Florbetapir, 18F-Florbetaben, or 18F-Flutemetamol), or Other standard PET tracers;
- Age ≥ 18 years old at time of consent;
- Able to provide informed consent; AND,
- Has the necessary mental capacity to understand instructions and is able to comply with protocol requirements.
Exclusion Criteria:
- Who, per the site's SOPs, has any condition that would prevent the clinically indicated PET/CT from proceeding (i.e., pregnancy, breastfeeding, renal impairment, elevated blood glucose, etc.);
- Who were previously enrolled in this study;
- Who need urgent or emergent care;
- Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results, constitute a health hazard for the subject;
- Unwilling to have GEHC personnel present during scans; OR,
- Unable to tolerate the exam.
Study Plan
How is the study designed?
Design Details
- Observational Models: OTHER
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Single Group Study
Adult patients scheduled to undergo a clinically indicated PET/CT |
Participants will undergo two PET/CT scans. The first scan will be performed on a commercially available PET/CT system as part of standard clinical care, and the second scan will be performed on the investigational Omni 128 cm PET/CT system. The investigational scan will begin within one hour of completion of the standard-of-care scan. No additional radiopharmaceutical tracer will be administered before the second imaging session. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Complete PET/CT Device Data Sets Collected
Time Frame: Through study completion, an average of 6 months
|
The primary outcome is the number of complete and evaluable PET/CT imaging datasets successfully collected from both the standard-of-care PET/CT scan and the investigational Omni 128 cm PET/CT scan. Device data may include PET raw scan data, PET list-mode data, PET DICOM images, and CT DICOM images. The collected data will be used to evaluate system performance and support future technology development, scientific assessment, and regulatory submissions. |
Through study completion, an average of 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Brian Thomsen, GE Healthcare
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Radiography
- Image Interpretation, Computer-Assisted
- Radiographic Image Enhancement
- Image Enhancement
- Photography
- Tomography, X-Ray
- Tomography, Emission-Computed
- Radionuclide Imaging
- Diagnostic Techniques, Radioisotope
- Positron-Emission Tomography
- Tomography, X-Ray Computed
- Multimodal Imaging
- Positron Emission Tomography Computed Tomography
Other Study ID Numbers
- SA-000165
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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