Positron Emission Tomography/Computed Tomography (PECT/CT) Double-Scanning Study
ConditionPET/CT
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGE Healthcare
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Omni 128cm PET/CT
DeviceParticipants 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Single Group Study1 intervention
Trial outcomes
Primary outcomes
1
Number of Complete PET/CT Device Data Sets Collected
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.
Time frame
Through study completion, an average of 6 monthsSponsors and contacts
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GE Healthcare
Lead sponsor
Stanford University
Collaborator
Source ClinicalTrials.gov