Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque
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|ClinicalTrials.gov Identifier: NCT01608516|
Recruitment Status : Recruiting
First Posted : May 31, 2012
Last Update Posted : November 15, 2016
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multimodal Assessment of the Inflammatory Atheromatous Plaque : Comparison Between 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, MRI AND US|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
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
- Comparison of each method of imaging for the detection of inflammatory atheromatous plaques [ Time Frame: 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.
- Comparison of AUC of the imaging methods [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608516
|Contact: John O. Prior, PhD, MD||+41 21 314 43 firstname.lastname@example.org|
|Contact: Emmanuel Deshayes, MD||+41 21 314 02 email@example.com|
|Centre Hospitalier Universitaire Vaudois||Recruiting|
|Lausanne, Vaud, Switzerland, 1011|
|Principal Investigator:||John O. Prior, PhD, MD||Lausanne University Hospitals|