NCT07857161|RecruitingFDA Device
Positron Emission Tomography/Computed Tomography (PECT/CT) Double-Scanning Study
Evaluation of Advancements in PET/CT Imaging
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Evaluation of Advancements in PET/CT Imaging
Sponsor study identifier
observational
60
1 country
1
Study Start
September 15, 2026
Actual (reported)Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 3, 2026
Actual (reported)September 15, 2026
Actual (reported)October 5, 2026
Actual (reported)March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Through study completion, an average of 6 months
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Stanford University
Stanford, California, 94305, United States
Brian Thomsen
GE Healthcare
First Submitted
September 3, 2026
First Posted
October 5, 2026
Study Start
September 15, 2026
Actual (reported)Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
PET/CT Follow up for Head and Neck Squamous Cell Carcinoma
Contact the study team to confirm eligibility.
Study Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 5, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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