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Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

Primary Purpose

Inflammation, Atheromatous Plaques, Carotid Artery Diseases

Status
Recruiting
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
68Ga-NODAGA-RGD PET/CT
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammation focused on measuring PET/CT, 68Ga-NODAGA-RGD, 18F-FDG, MRI, US ultrasound, inflammatory atheromatous plaque, endarterectomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier Universitaire VaudoisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-NODAGA-RGD radiotracer

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 16, 2012
Last Updated
July 13, 2023
Sponsor
University of Lausanne Hospitals
Collaborators
Swiss Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01608516
Brief Title
Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque
Official Title
Multimodal Assessment of the Inflammatory Atheromatous Plaque : Comparison Between 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, MRI AND US
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2012 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
Collaborators
Swiss Heart Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Atheromatous Plaques, Carotid Artery Diseases
Keywords
PET/CT, 68Ga-NODAGA-RGD, 18F-FDG, MRI, US ultrasound, inflammatory atheromatous plaque, endarterectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-NODAGA-RGD radiotracer
Arm Type
Experimental
Arm Description
All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT, a MRI and a US.
Intervention Type
Radiation
Intervention Name(s)
68Ga-NODAGA-RGD PET/CT
Intervention Description
200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images centred on the carotid area acquired
Primary Outcome Measure Information:
Title
Comparison of each method of imaging for the detection of inflammatory atheromatous plaques
Description
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.
Time Frame
Within1 month of endarterectomy
Secondary Outcome Measure Information:
Title
Comparison of AUC of the imaging methods
Description
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.
Time Frame
Within1 month of endarterectomy
Title
Analysis of histopathological sample of endarterectomy
Description
The histopathological analysis will be the degree of local inflammation estimated by the macrophagic infiltration as well as the degree of neovascularization.
Time Frame
Within1 month of endarterectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John O. Prior, PhD, MD
Phone
+41 21 314 43 48
Email
john.prior@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel Deshayes, MD
Phone
+41 21 314 02 20
Email
emmanuel.deshayes@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John O. Prior, PhD, MD
Organizational Affiliation
Lausanne University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28523582
Citation
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.
Results Reference
derived

Learn more about this trial

Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque

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