Phase I Study, Prospective, Monocentric, Uncontrolled, Non-randomized, Open, Interventional. First Human Administration of an Inflammation Tracer (99mTc-cAbVCAM1-5) Using the Scintigraphy in Healthy Volunteers and Asymptomatic Patients.

38RC19.051

Clinical Transfer of a Tracer of the Vulnerable Atheroma Plate: 99mTc-cAbVCAM1-5. (ATHENA). This is a phase I/IIa, prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.

2020-09-15

2023-05-01

2023-05-01

Active (not recruiting)

Early phase I

13

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '7 healthy volunteers (1+3+3) and 6 asymptomatic patients', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 13, 'type': 'ACTUAL'}}

2023-05-23