Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inflammation Atheromatous Plaques Carotid Artery Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-NODAGA-RGD radiotracer

All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT, a MRI and a US.

Group Type EXPERIMENTAL

68Ga-NODAGA-RGD PET/CT

Intervention Type DRUG

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

Interventions

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68Ga-NODAGA-RGD PET/CT

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No