This clinical trial compares image quality of two positron emission tomography (PET)/computed tomography (CT) imaging devices; conventional mCT PET/CT and uEXPLORER PET/CT in patients with lung cancer, lymphoma and melanoma. uEXPLORER is the world’s first PET/CT capable of imaging the whole body simultaneously. Conventional PET/CT scanners take images of one part of the body at a time, then stitch them all together to form a whole-body image. By imaging the whole body at the same time, uEXPLORER PET/CT can acquire images of the body faster. Shortening scan times has the advantages of decreasing discomfort, limits the possibility of motion, and for children, it may decrease the need for anesthesia which is currently required to perform a PET/CT scan. On the other hand, shortening scan time may make the image quality worse. Image quality is the feature that makes the scan clear to the eyes of the doctor that is interpreting the test. This clinical trial may help researchers study what is the best balance in terms of image quality and scanning time to provide future patients with the best care.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04478318.
PRIMARY OBJECTIVE:
I. To determine the minimum scan duration for fludeoxyglucose F-18 (18F-FDG) PET/CT scans performed on a total-body PET/CT scanner that results in non-inferior image quality to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner over 20 minutes.
SECONDARY OBJECTIVES:
I. To determine the minimum scan duration for 18F-FDG PET/CT scans performed on a total-body PET/CT scanner that results in non-inferior tumor conspicuity to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner over 20 minutes (with an additional 2 minutes of data used for optimization purposes).
II. To select optimal delayed timepoints for EXPLORER imaging by determining differences in signal to noise ratio (lesion conspicuity) within the tumoral lesions at different time points (3, 6 and 9 hours post injection).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive 18F-FDG via injection, then 90 minutes later undergo PET/CT on the uEXPLORER over 22 minutes. At 120 minutes post-injection, patients undergo PET/CT on the mCT over 22 minutes. Patients may also undergo PET/CT on the uEXPLORER over 22-30 minutes at 3, 6, and 9 hours post-injection.
ARM 2: Patients receive 18F-FDG via injection, then 90 minutes later undergo PET/CT on the mCT over 22 minutes. At 120 minutes post-injection, patients undergo PET/CT on the uEXPLORER over 22 minutes. Patients may also undergo PET/CT on the uEXPLORER over 22-30 minutes at 3, 6, and 9 hours post-injection.
After completion of study treatment, patients are followed up for up to 30 days.
Trial PhaseNo phase specified
Trial Typedevice
Lead OrganizationUniversity of California Davis Comprehensive Cancer Center
Principal InvestigatorLorenzo Nardo
