Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque
Recruitment status was Recruiting
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.
Carotid Artery Diseases
Radiation: 68Ga-NODAGA-RGD PET/CT
|Study Design:||Intervention Model: Single Group Assignment
Masking: 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|
- 68Ga-NODAGA-RGD PET/CT [ Time Frame: day -1 before planned endarterectomy ] [ Designated as safety issue: Yes ]
60 minutes after radiotracer injection, images centred on the carotid area will be acquired and SUVmax, SUV90%carotids/SUVbackground measured.
The 5 first patients/20 will have a total body imaging acquisition for tracer biodistribution assessment and dosimetric study.
- US Doppler with microbubbles [ Time Frame: day -6 to day -2 before planned endarterectomy ] [ Designated as safety issue: No ]gray scale median analysis
- 18F-FDG PET/CT [ Time Frame: day -6 to day -2 before planned endarterectomy ] [ Designated as safety issue: No ]45 minutes after radiotracer injection, images centred on the carotid area will be acquired and SUVmax, SUV90%carotids/SUVbackground measured
- MRI [ Time Frame: day -1 before planned endarterectomy ] [ Designated as safety issue: No ]MRI images centred on the carotid area will be acquired using sequences before and after gadolinium administration
- Histopathology [ Time Frame: within 1 month of endarterectomy ] [ Designated as safety issue: No ]Degree of local inflammation measured by macrophagic infiltration on anti-CD68 IHC coloration and degree of neovascularization on HES coloration.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: 68Ga-NODAGA-RGD radiotracer
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608516
|Contact: John O. Prior, PhD, MD||+41 21 314 43 email@example.com|
|Contact: Emmanuel Deshayes, MD||+41 21 314 02 firstname.lastname@example.org|
|Centre Hospitalier Universitaire Vaudois||Recruiting|
|Lausanne, Vaud, Switzerland, 1011|
|Principal Investigator:||John O. Prior, PhD, MD||Lausanne University Hospitals|