Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

Sponsor

University of Lausanne Hospitals (Other)

Overall Status

Recruiting

CT.gov ID

NCT01608516

Collaborator

Swiss Heart Foundation (Other)

Enrollment

Location

Arm

128

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Atheromatous Plaques Carotid Artery Diseases	Radiation: 68Ga-NODAGA-RGD PET/CT	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 68Ga-NODAGA-RGD radiotracer 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 200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images centred on the carotid area acquired

Arm

Intervention/Treatment

Experimental: 68Ga-NODAGA-RGD radiotracer

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

200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images centred on the carotid area acquired

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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