Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Lausanne Hospitals
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age <= 85 years
Karnofsky >= 80%
patient with indication ofr carotid endarterectomy
signed consent form
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-NODAGA-RGD PET/CT
Drug200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images centred on the carotid area acquired
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: 68Ga-NODAGA-RGD radiotracerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within1 month of endarterectomySecondary outcomes
1
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.
Time frame
Within1 month of endarterectomy2
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.
Time frame
Within1 month of endarterectomySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Lausanne Hospitals
Lead sponsor
Swiss Heart Foundation
Collaborator
Source ClinicalTrials.gov