Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT06398392
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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06398392
Study Brief:
Protocol Section:
NCT06398392