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

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Abdominal aortic aneurysm
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Brief Title

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

Official Title

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

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.

Detailed Description

      Background:

      Abdominal Aorta Aneurysm(AAA) is a frequently occurring atherothrombotic disease, linked to
      male gender and aging. Due to the current aging of the population, the incidence of rupture
      may be increasing. The clinical evaluation of AAA usually includes a morphological
      assessment(size and localization) for diagnosis, open surgery or endovascular prosthesis
      (EVAR) may be indicated to prevent the onset of a rupture which is often lethal.
      Unfortunately, the durability of endovascular repair of AAA remains uncertain and the rupture
      risk or endoleaks onset requires continuous surveillance and the conventional imaging by CT
      scan often fails to predict this negative progression.

      Our hypothesis is that the therapeutic efficacity of endovascular surgery in the AAA is
      linked to the restoration of effective compartmentalization between the blood and the outer
      wall (removal of the thrombosis interface and blood pressure constraint). Thus, success of
      EVAR must be followed by the disappearance of adventitial inflammation visualized by
      metabolic activity in FDG-PET (18FDG uptake) and a normalization of biological markers of the
      injury. Conversely, the inefficacy of endovascular therapy should result in the persistence
      of an inflammatory metabolic activity in relation to the saccular endoleak and a persistent
      elevation of plasma biomarkers.

      Primary objective:

      The general aim of this pilot study is to assess the effect of endoprosthesis treatment on
      PET scan functional imaging of AAA.

      Materials and method:

      Seven French Hospitals will recruit 50 patients presenting a large AAA scheduled for EVAR
      (Endovascular prosthesis) within one month. A 18FDG PET scan 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, biological markers of the inflammation, proteolysis and coagulation potentially
      related to morphology and evolution of AAA will be investigated by the U698 (National
      Institute for Medical Research) Unit, implementing already existing database from others
      cohorts of patients with AAA, including biological samples conserved both by the Nancy
      clinical investigation center and the (U698) National Institute for Medical Research Unit.

      Study duration for a patient: 26 months

      Perspectives:

      This pilot study will help to assess the effect of EVAR in terms of it functional
      inflammatory response and determine the required sample size for a future project. Since
      aneurysm expansion rate varies widely among patients and even for one single patient over
      time, studying metabolic adventitial immuno-inflammatory activity using 18FDG PET imaging
      will provide new major informations about the efficacity of endovascular therapy in AAA.
      Plasma assays will help to identify intermediate biological markers of aneurysm evolutivity
      after endovascular therapy. Those complementary functional and biological criteria are of
      paramount importance to improve therapeutic management and prognosis of AAA.

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

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

Condition

Abdominal Aortic Aneurysm

Intervention

[18F] Fluorodeoxyglucose PET Scan Imaging

Study Arms / Comparison Groups

 Specific procedure
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Radiation

Estimated Enrollment

45

Start Date

August 2009

Primary Completion Date

August 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Large AAA scheduled for endovascular surgery within one month

          -  Written informed consent

        Exclusion Criteria:

          -  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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Patrick ROSSIGNOL, MD, phD, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT01253252

Organization ID

2007-A01424-49

Responsible Party

Sponsor

Study Sponsor

Central Hospital, Nancy, France

Collaborators

 Institut National de la Santé Et de la Recherche Médicale, France

Study Sponsor

Patrick ROSSIGNOL, MD, phD, Principal Investigator, Nancy's Hospital, Plurithematic Clinical Investigation Centre

Verification Date

July 2017