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Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

L

Lausanne University Hospital (CHUV)

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Atheromatous Plaques
Inflammation
Carotid Artery Diseases

Treatments

Drug: 68Ga-NODAGA-RGD PET/CT

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

68Ga-NODAGA-RGD radiotracer
Experimental group
Description:
All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT, a MRI and a US.
Treatment:
Drug: 68Ga-NODAGA-RGD PET/CT

Trial contacts and locations

1

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Central trial contact

Emmanuel Deshayes, MD; John O. Prior, PhD, MD

Data sourced from clinicaltrials.gov

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