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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04483167
Eligibility Criteria:
Inclusion Criteria:
Healthy volunteers:
* Ages 18-55
* No nuclear imaging or CT scans in the year prior to inclusion
* A person not exposed to ionizing radiation according to the labour code.
Patients:
* Ages between 18 and 80
* Atherosclerosis with asymptomatic carotid atheroma plate.
* Indication of carotid endarterectomy.
All:
* Person affiliated with or benefiting from social security
* Person who has given written informed consent
Non inclusion Criteria:
* Woman of childbearing potential in the absence of highly effective contraception or man of childbearing potential without mechanical contraception.
* Medical history that significantly interferes with biodistribution
* History of disease which may impair the absorption, diffusion and excretion of the radiopharmaceutical: Crohn's disease, celiac disease.
* Known allergy to one of the constituents of the product.
* Intoxication with alcohol or drugs on purpose
* Grade 3 haematological toxicity for the following parameters : Hemoglobin, platelets, leukocytes and neutrophil polynuclear cells.
* Grade 2 renal toxicity for the following parameters: Urea and creatinine and/or Glomerular filtration rate according to the CPK-EPI formula \< 60mL/min/1.73m².
* Grade 2 liver toxicity for the following parameters : AST, ALT, GGT, PAL and bilirubin.
* Grade 2 pancreatic toxicity for the following parameter: lipase.
* Blood or urine pregnancy test (confirmed in blood) inconclusive or positive for women of childbearing potential.
* Participation in other research involving the type 1 or 2 human being at the same time
* Person in a period of exclusion from other research involving the human person
* Living conditions suggesting an inability to follow all the visits provided for in the protocol.
* Subject who would receive more than 4,500 euros in compensation as a result of participation in other research involving the human person in the 12 months preceding this study.
* Subject not contactable in case of emergency
* Protected person (Sections L1121-5 to L1121-8 of the CSP)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04483167
Study Brief:
Protocol Section:
NCT04483167