Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multimodal Assessment of the Inflammatory Atheromatous Plaque : Comparison Between 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, MRI AND US

Conditions
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Inflammation, Atheromatous Plaques, Carotid Artery Diseases

Intervention / Treatment
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* Radiation: 68Ga-NODAGA-RGD PET/CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-NODAGA-RGD radiotracer<br>All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT, a MRI and a US. | Radiation: 68Ga-NODAGA-RGD PET/CT<br>* 200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images centred on the carotid area acquired<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of each method of imaging for the detection of inflammatory atheromatous plaques | 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. | Within1 month of endarterectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of AUC of the imaging methods | 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. | Within1 month of endarterectomy | 
| Analysis of histopathological sample of endarterectomy | The histopathological analysis will be the degree of local inflammation estimated by the macrophagic infiltration as well as the degree of neovascularization. | Within1 month of endarterectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, 68Ga-NODAGA-RGD, 18F-FDG, MRI, US ultrasound, inflammatory atheromatous plaque, endarterectomy