Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03491059 |
| Other study ID # |
SP0232/2017H0463 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
February 16, 2018 |
| Est. completion date |
February 16, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
University of Cincinnati |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
E-cigarette manufactures claim that e-cigarettes are safer than conventional cigarettes and
that they may aid in smoking cessation. As a result, e-cigarettes are gaining popularity and
use in the general public as a replacement for traditional cigarettes. However, little is
known about the benefits and health risks of e-cigarette use. Although e-cigarettes have been
shown to have negligible effect on carbon monoxide exposure and heart rate, they contain a
variety of glycerols mixed with variable concentrations of nicotine. In addition, other
substances are present in the refill solutions and/or resulting vapor, such as tobacco
specific nitrosoamines, cotinine, aldehydes, metals, volatile organic compounds, tobacco
alkaloids, and other pharmacologically active ingredients (although in concentrations much
lower than in combustible traditional cigarettes). In addition, studies have shown that
during the atomization process, there is a large range in the size of the particulate matter
formed that is dependent upon both the device and refill solution used. It is well know that
inhaled particulate matter may induce inflammation and may eventually lead to an increase in
a variety of health risks including cardiovascular disease and emphysema. Although
e-cigarettes are not currently regulated, studies have indicated that the e-liquid products
should be regulated to ensure consistent nicotine delivery and to prohibit the use of
ethylene glycol and other excipients that currently may be present at potentially harmful
levels (high risk category). Additionally, only minimal valid data is available related to
the biodistribution (deposition of nicotine and/or aerosol excipients) following inhalation.
The evaluation of nicotine and aerosol deposition in the body will help to determine if the
particulates formed during the atomization process may induce any serious health risks.
Additionally, this data may be compared to traditional cigarette smoking to determine if
e-cigarettes are truly a safer alternative to conventional cigarettes. In order to provide
this data, quantitative methods need to be developed that allow for accurate in vivo
biodistribution determination following inhalation.
To determine eligibility, participants will sequentially complete two eligibility surveys
that include questions related to their use of e-cigarettes, tobacco cigarettes, other
tobacco products, and pharmaceuticals. The brochures and social media postings will include a
link to Eligibility Survey 1. Survey 1 will collect sensitive, medical information, but will
be completely anonymous. Medical information will be collected solely for the purposes of
determining participant eligibility and will be unlinked from any identifying participant
information as well as future collected study data. Once participants are determined eligible
by Survey 1, they will be directed to complete Survey 2 to confirm their eligibility. Survey
2 will ask participants questions about their vaping habits. If they are confirmed eligible
from the survey, they will also be asked to provide their name and contact information
(e-mail). Study personnel will then contact eligible participants to schedule a time for them
to come to the WCIBMI for their initial visit. Responses from Survey 1 and Survey 2 will be
completely unlinked to maintain anonymity about participants' medical information. Once the
participant has been deemed eligible and indicated interest in participation, they will be
invited to the WCIBMI to see the facilities, and the relevant consent form will be reviewed
and signed. Participants will either participate solely in a dress rehearsal of the study, or
they will participate in both a dress rehearsal and the full imaging study. During the dress
rehearsal, participants will walk through the study process without the use of the
11C-nicotine e-cigarette and without performing any imaging. The participant will first
disrobe and change to hospital scrubs. The subject will also wear full-body disposable
personal protective equipment (PPE) including a gown, hairnet, double latex gloves, and foot
coverings. Then, the subject will lay on the bed of the PET/CT imaging system and practice
puffing in the supine position, the proper posture for PET scanning, and exhaling into the
gas traps. Participants who are only participating in the dress rehearsal will use their own,
personal e-cigarette to vape in the system. For participants who are participating in the
full study, the investigators will provide them with the e-cigarette that they will use in
the full study. Urine will be collected from female participants of the full study to confirm
that they are not pregnant. During the study, first, S-nicotine will be labeled with C11 and
placed in the cartridge of an e-cigarette. The S-nicotine may be given in two different
doses. The investigators will focus on the 3 mCi C11 (Dose Level A) in the e-cigarette at the
time of initial inhalation previously purified by HPLC. If 3 mCi does not yield adequate
image quality, the dosage will be increased to 9 mCi (Dose Level B) for subsequent
participants. To determine the appropriate dose level, the imaging scans will be reviewed
independently at a minimum by three experienced investigators (Michael V. Knopp, Chadwick
Wright, and Jun Zhang). Once the C11 labeled e-cigarette enters the facility, it may be
placed in the dose calibrator for secondary dose confirmation and then transported directly
to the imaging room. The subject will then be instructed to start inhalation (maximum 10
puffs at 30 second intervals) while positioned in the PET/CT system. Afterwards, the
e-cigarette will be removed from the imaging system by a staff member, and the remaining
activity of the E-liquid will be determined using a dose calibrator. PET/CT imaging will then
be performed for a maximum of 60 minutes following inhalation. The subject will be placed in
the PET camera as to generate axial slices in the following sectors: the brain, oral cavity,
throat, and lungs. From the PET/CT images, quantitative radioactivity deposition will be
determined, and the biodistribution and uptake/clearance will be evaluated. Acquired data
will be used for listmode based simulation to determine the potentially lowest dose feasible
using new digital PET/CT technology. After scanning, the subject will be removed from the
imaging suite and will be asked to stay in the patient waiting/recovery area for up to 120
minutes (2 hours). Prior to release, the subject will be surveyed to ensure that any
exhaled/emitted air is at background levels with respect to radiation. Additionally, all
subjects will be contacted within 12 to 48 hours after release from the study to ensure that
they are feeling well and have not experienced any adverse reaction to the study. Any adverse
reactions will be recorded and reported immediately to the PI.
