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NCT05074537
This data bank will serve as a data resource for a multidisciplinary team of clinicians and basic scientists. Specifically, this data bank will allow investigators to generate preliminary data for competitive consideration in intermural and extramural funding while enabling advanced analytical tool development and deep learning methodologies. This effort will enable the use for leading edge innovation in biomedical imaging by using clinical imaging studies that otherwise could not be used for such developments. We aim to use these data to improve diagnostics and disease management. With this data bank, we hope to improve the quality of imaging and the precision of imaging based analytics to better detect potential health risks, predict treatment response, and monitor disease progression in order to guide management of future patients.
NCT03491059
The investigators aim to (1) establish a methodology for the evaluation of the biodistribution of radio-labeled nicotine following e-cigarette use, (2) determine the oral/pulmonary distribution of nicotine following e-cigarette use, and (3) determine the lowest required dose using the new digital PET/CT technology to provide detailed or accurate oral/pulmonary distribution data following e-cigarette use. Potential participants will be identified using advertisements such as brochures and online social media postings. After participants are identified, their eligibility will be determined using survey tools. All eligible participants will first have a screening visit at the WCIBMI for study participation. During this initial visit, subjects will be informed about the study in detail, and the relevant consent form will be reviewed and signed. If the participant agrees to participate, they will go through a full dress rehearsal. Up to 10 volunteers will only participate in the dress rehearsal. All other volunteers (30) will have a dress rehearsal without radiation exposure on day 1, and then on a second day, they will participate in the full imaging study using 11C-nicotine. During the imaging study, S-nicotine will be labeled with 11C and placed in the cartridge of an e-cigarette. There will be two dose groups: (A) 3 mCi dosage or (B) 9 mCi doses. The investigators intend to use dose level A; however, if it does not lead to the expected results, an alternate dose level as an option is needed, which is the 9 mCi (B) dose level. Subjects will take a maximum of 10 puffs (1 puff per 30 seconds) from the e-cigarette while positioned in the PET/CT system. Dynamic PET/CT imaging will be performed for a maximum of 60 minutes following inhalation. The subject will be placed in the PET camera in order to generate axial images of the following regions: head/neck (e.g., brain, oral cavity, and throat) and thorax (e.g., trachea, lungs). From the PET/CT images, quantitative radioactivity deposition will be determined, and the biodistribution and uptake/clearance will be evaluated. PET data will be acquired in listmode and subsequently used for simulation to determine the potentially lowest dose feasible using the next generation digital PET/CT technology.