Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01608516
• Other study ID #: 80/10
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2012
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: University of Lausanne Hospitals
• Contact: John O. Prior, PhD, MD
• Phone: +41 21 314 43 48
• Email: john.prior[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atheromatous Plaques
• Carotid Artery Diseases
• Inflammation
• Plaque, Atherosclerotic

Intervention

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

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	Swiss Heart Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within1 month of endarterectomy
Secondary	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.	Within1 month of endarterectomy
Secondary	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.	Within1 month of endarterectomy