Endoprosthesis Treatment Effects on Human Abdominal Aorta Aneurysms(AAA)Metabolic Activity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 14
- Primary Endpoint
- Difference of 18FDG PET scan signal (mean and maximal aortic standardized uptake measurements) visualized before and after endoprosthesis implantation for AAA treatment.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Specific procedure
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.
Intervention: [18F] Fluorodeoxyglucose PET Scan Imaging (Radiation)
Specific procedure
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.
Intervention: CT scan (Radiation)
Specific procedure
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.
Intervention: Blood sampling for biological investigations (Biological)
Outcomes
Primary Outcomes
Difference of 18FDG PET scan signal (mean and maximal aortic standardized uptake measurements) visualized before and after endoprosthesis implantation for AAA treatment.
Time Frame: 3 Pet scan will be performed: within one month before surgery and after 1 and 6 months of follow-up
Secondary Outcomes
- 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)