Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

NCT01608516 | Recruiting Phase 1

• 1 other identifier: 80/10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation; Atheromatous Plaques; Carotid Artery Diseases

Keywords

PET/CT; 68Ga-NODAGA-RGD; 18F-FDG; MRI; US ultrasound; inflammatory atheromatous plaque; endarterectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of AUC of the imaging methods

  Within1 month of endarterectomy

• Analysis of histopathological sample of endarterectomy

  Within1 month of endarterectomy

Study Arms (1)

68Ga-NODAGA-RGD radiotracer

EXPERIMENTAL

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

Drug: 68Ga-NODAGA-RGD PET/CT

Interventions

68Ga-NODAGA-RGD PET/CT DRUG

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

68Ga-NODAGA-RGD radiotracer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \<= 85 years
• Karnofsky \>= 80%
• patient with indication ofr carotid endarterectomy
• signed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead
• Swiss Heart Foundation: collaborator

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (1)

• Gnesin S, Mitsakis P, Cicone F, Deshayes E, Dunet V, Gallino AF, Kosinski M, Baechler S, Buchegger F, Viertl D, Prior JO. First in-human radiation dosimetry of 68Ga-NODAGA-RGDyK. EJNMMI Res. 2017 Dec;7(1):43. doi: 10.1186/s13550-017-0288-x. Epub 2017 May 18.

  PMID: 28523582 DERIVED

MeSH Terms

Conditions

Inflammation; Plaque, Atherosclerotic; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• John O. Prior, PhD, MD

  Lausanne University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John O. Prior, PhD, MD

CONTACT

+41 21 314 43 48; john.prior@chuv.ch

Emmanuel Deshayes, MD

CONTACT

+41 21 314 02 20; emmanuel.deshayes@chuv.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Nuclear Medicine

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: May 31, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)