In Vivo Study of Neuroinflammation in Tobaccosmoking: a Clinical PET Study of TSPO Using [18F]PBR111

Launched by PROF. DANIELE ZULLINO · May 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how smoking tobacco affects the brain, specifically looking at a process called neuroinflammation, which is when the brain's immune system responds to damage or irritation. Researchers want to use a special type of imaging called PET/CT scanning to measure a substance in the brain related to this inflammation. However, the imaging agent they plan to use has not yet been approved for use in humans in Switzerland, so the study is still in the early stages and has not started recruiting participants.

To be eligible for this trial, participants need to be at least 18 years old and fluent in French. The study is looking for both men and women, but there are some important criteria that could exclude someone from participating, such as having certain genetic traits or medical conditions that could affect the study results. Participants can expect to undergo imaging scans and provide informed consent, meaning they will be fully informed about the study and agree to take part. It's also important to note that women will need to have stable contraception to avoid any risks related to pregnancy during the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged ≥18 (3 male and 3 female participants)
• • Fluent in French and able and willing to provide written informed consent.
• Exclusion Criteria:
• • Homozygosity for the rs6971 polymorphism on TSPO that results in low-affinity binding. This criterion is added because this polymorphism alters significantly the ability of the radiotracer \[18F\]PBR111 to bind to TSPO, hence precluding quantification.
• • Absence of a stable contraceptive regimen (specifically, intrauterine contraceptive device or contraceptive treatment per os). Only women with stable contraception will be added to eliminate the risk of exposure of pregnant women and their foetus to radioactivity.
• • Presence of any significant history or current diagnosis of chronic disease or syndrome (including neurological, psychiatric, cardiovascular, oncological, metabolic, rheumatological conditions).
• • One or more episode(s) of acute infectious or allergic reaction in the last month before inclusion and during the study period. Again, we cannot exclude that such conditions might produce immune alterations in the brain, thus confounding the results of TSPO quantification with \[18F\]PBR111.
• • Presence of clinically relevant laboratory abnormalities in the haematological and biochemical blood tests, as defined as laboratory values that require clinical workup and/or treatment (e.g. anaemia, hyperglycaemia, electrolyte imbalances)
• • A body mass index \<20 or \>30 (this criterion is necessary because TSPO has been shown to be variable with respect to body mass index (113-115)).
• • Exposure to research related radiation in the past five years that, when combined with this study, would place subjects above the allowable limits.
• • Conditions precluding entry into the scanners (e.g. claustrophobia).