Atheromatous Plaques, Carotid Artery Diseases, Inflammation
Conditions
Keywords
PET/CT, 68Ga-NODAGA-RGD, 18F-FDG, MRI, US ultrasound, inflammatory atheromatous plaque, endarterectomy
Brief summary
The present study aims at assessing the ability of 68Ga-NODAGA-RGD PET/CT for the detection of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET/CT, MRI and US and to determine the contribution of each imaging technique. Current gold standard for inflammation is histopathology. Hypothesis : 68Ga-NODAGA-RGD might give a better initial evaluation of patients with atheromatous plaques in the carotid artery eligible for endarterectomy.
Detailed description
Patients with indication for endarterectomy will be presented the present protocol. If inclusion criteria are fulfilled, patients will have a 18F-FDG PET/CT + carotid US performed 6 to 2 days before endarterectomy and 68Ga-NODAGA-RGD PET/CT + MRI performed the day before endarterectomy. Histopathological sample will be analyzed to measure plaque inflammation. All imaging results and histopathology results will be pooled and compared.
Interventions
200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images centred on the carotid area acquired
Sponsors
University of Lausanne Hospitals
Swiss Heart Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* age \<= 85 years * Karnofsky \>= 80% * patient with indication ofr carotid endarterectomy * signed consent form
Exclusion criteria
* indication for surgery other than endarterectomy \<14 days * contraindication to surgery * contraindication to MRI * contraindication to gadolinium injection (stage 4/5 kidney insufficiency, GFR\<30ml/min/1.73m2) * pregnancy, breastfeeding * lack of discernment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of each method of imaging for the detection of inflammatory atheromatous plaques | Within1 month of endarterectomy | The potential of each of the methods of imaging for the detection of inflammatory atheromatous plaques will be compared. For that purpose, the capacity of every criterion of primary assessment to determine the presence of an unstable plaque will be studied compared with the histopathological sample. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of AUC of the imaging methods | Within1 month of endarterectomy | A comparison of the AUC will be realized to determine the superiority of a method compared with the other one, by a non parametric test comparing AUC , ROC curves respectively. |
| Analysis of histopathological sample of endarterectomy | Within1 month of endarterectomy | The histopathological analysis will be the degree of local inflammation estimated by the macrophagic infiltration as well as the degree of neovascularization. |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORJohn O. Prior, PhD, MD
Lausanne University Hospitals
Outcome results
None listed