Feasibility of PET/CT to Detect the Oral/Pulmonary Distribution of Nicotine Following E-cigarette Use
Status:
Recruiting
Trial end date:
2025-02-16
Target enrollment:
Participant gender:
Summary
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.