Status:
UNKNOWN
Clinical Transfer of a Vulnerable Atherosclerotic Plaque Tracer : 99mTc-cAbVCAM1-5 (ATHENA)
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Cardiovascular Diseases
Atherosclerosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief 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...
Detailed Description
Cardiovascular disease (CVD) is the leading cause of death worldwide with more than 17.6 million deaths. Of these 17.6 millions deaths, 15 millions (85.1%) are attributable to coronary heart disease a...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04483167
Start Date
September 15 2020
End Date
May 1 2023
Last Update
May 23 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Grenoble Alpes University Hospital
Grenoble, France, 38043