Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

Phase 1

Recruiting

• Conditions: Inflammation; Atheromatous Plaques; Carotid Artery Diseases
• Interventions: Drug: 68Ga-NODAGA-RGD PET/CT

• Registration Number: NCT01608516
• Lead Sponsor: University of Lausanne Hospitals

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-05-28
• Study First Posted: 2012-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NODAGA-RGD radiotracer	68Ga-NODAGA-RGD PET/CT	All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT, a MRI and a US.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland