Endoprosthesis Treatment Effects on Human Abdominal Aorta Aneurysms (AAA) Metabolic Activity

NCT01253252 | Completed

• 1 other identifier: 2007-A01424-49
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine whether Positron Emission Tomography imaging can help to predict the evolutivity of AAA treated with endovascular prosthesis.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm; Prosthesis; Fluorodeoxyglucose F18; Positron-emission Tomography; Spiral computed tomography; Biological markers

Outcome Measures

Primary Outcomes (1)

• Difference of 18FDG PET scan signal (mean and maximal aortic standardized uptake measurements) visualized before and after endoprosthesis implantation for AAA treatment.

  3 Pet scan will be performed: within one month before surgery and after 1 and 6 months of follow-up

Secondary Outcomes (2)

• Correlation between therapeutic efficacity of endovascular treatment and AAA injury biological markers.

  Blood samplings will be performed 5 times: within one month before endoprosthesis implantation and after one month, six months, one year and 2 years of follow-up

• Relationship between efficacity of endovascular surgery and morphology of the AAA as assessed by CT scan.

  CT scan will be performed within one month before endoprosthesis implantation and at one month, six months, one year and two years of follow-up

Study Arms (1)

Specific procedure

EXPERIMENTAL

A \[18F\] Fluorodeoxyglucose PET Scan Imaging will be added to their conventional follow up (CT scan, usual blood sampling, ECG…) i.e. within one month before endovascular surgery (inclusion visit), at one month and 6 month of follow-up. Furthermore, blood sampling for biological investigations (biological markers of the inflammation, proteolysis and coagulation potentially related to morphology and evolution of AAA) will be done.

Radiation: [18F] Fluorodeoxyglucose PET Scan Imaging; Radiation: CT scan; Biological: Blood sampling for biological investigations

Interventions

[18F] Fluorodeoxyglucose PET Scan Imaging RADIATION

Positron Emission Tomography (PET) is a nuclear medicine imaging technique which produces a 3-dimensional image of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide, which is introduced into the body on a biologically active molecule. Images of tracer concentration in 3-dimensional space are then reconstructed by computer analysis. The biologically active molecule chosen for PET is 18-fluorodeoxyglucose. The concentrations of tracer imaged then give tissue metabolic activity, in terms of regional glucose uptake. The dose of 18FDG that is recommended for adults in a standard exploration varies from 200 to 500 MBq according to the weight of the patient and the camera used. No allergic or other incident has been observed after several thousands of examinations.

Specific procedure

CT scan RADIATION

Computed tomography (CT) is a medical imaging method employing tomography created by computer processing. Digital geometry processing is used to generate the PET's three-dimensional space image.

Specific procedure

Blood sampling for biological investigations BIOLOGICAL

A venous blood sample of a total of 30 ml for measurement of enzymes associated with the development of aneurysms (= biomarkers).

Specific procedure

Eligibility Criteria

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

You may qualify if:

• Large AAA scheduled for endovascular surgery within one month
• Written informed consent

You may not qualify if:

• Evolutive neoplasm
• Chronic liver disease
• Connective tissue diseases: rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Crohn's disease, polymyositis/dermatomyositis, mixed connective tissue disease
• Crohn's disease
• Evolutive tuberculosis
• Contraindication to CT scan
• Pregnancy and breastfeeding
• Women of child bearing potential
• Patient unable to understand the study aims
• Patient unable to comply with scheduled visit
• Participation in other investigational studies.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (7)

Le Bocage - Dijon's Hospital

Dijon, 21 000, France

Location

Cardiologic Hospital

Lille, 59037, France

Location

Brabois Hospital

Nancy, 54500, France

Location

Institut du Thorax, Nantes's Hospital

Nantes, 44 093, France

Location

Bichat Claude Bernard Hospital

Paris, 75018, France

Location

Georges Pompidou European Hospital

Paris, 75908, France

Location

CH.NICOLLE's Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Patrick ROSSIGNOL, MD, phD

  Nancy's Hospital, Plurithematic Clinical Investigation Centre

  PRINCIPAL INVESTIGATOR

• Jean-Baptiste MICHEL, MD, PhD

  Institut National de la Santé Et de la Recherche Médicale (INSERM) U698 FRANCE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: December 3, 2010
• Study Start: August 1, 2009
• Primary Completion: August 1, 2009
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

FR (7)