Clinical Transfer of a Vulnerable Atherosclerotic Plaque Tracer : 99mTc-cAbVCAM1-5 (ATHENA)

• Status: Not yet recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Grenoble

Criteria

Inclusion Criteria:

Healthy volunteers:

1. Ages 18-55

2. No nuclear imaging or CT scans in the year prior to inclusion

3. A person not exposed to ionizing radiation according to the labour code.

Patients:

1. Ages between 18 and 80

2. Atherosclerosis with asymptomatic carotid atheroma plate.

3. Indication of carotid endarterectomy.

All:

4. Person affiliated with or benefiting from social security

5. Person who has given written informed consent

Non inclusion Criteria:

1. Woman of childbearing potential in the absence of highly effective contraception or man of childbearing potential without mechanical contraception.

2. Medical history that significantly interferes with biodistribution

3. History of disease which may impair the absorption, diffusion and excretion of the radiopharmaceutical: Crohn's disease, celiac disease.

4. Known allergy to one of the constituents of the product.

5. Intoxication with alcohol or drugs on purpose

6. Grade 3 haematological toxicity for the following parameters : Hemoglobin, platelets, leukocytes and neutrophil polynuclear cells.

7. 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.

8. Grade 2 liver toxicity for the following parameters : AST, ALT, GGT, PAL and bilirubin.

9. Grade 2 pancreatic toxicity for the following parameter: lipase.

10. Blood or urine pregnancy test (confirmed in blood) inconclusive or positive for women of childbearing potential.

11. Participation in other research involving the type 1 or 2 human being at the same time

12. Person in a period of exclusion from other research involving the human person

13. Living conditions suggesting an inability to follow all the visits provided for in the protocol.

14. 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.

15. Subject not contactable in case of emergency

16. Protected person (Sections L1121-5 to L1121-8 of the CSP)