Back to resultsFDG PET-Scan Analysis of Evolutivity of Non-surgical Aneurysm of Abdominal Aorta (AAA)
Primary Purpose
Medically-treated Aneurysm of Abdominal Aorta
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET-Scan
Sponsored by
About this trial
This is an interventional screening trial for Medically-treated Aneurysm of Abdominal Aorta focused on measuring Aneurysm of abdominal aorta, 18F-fluorodesoxyglucose (FDG-F18)
Eligibility Criteria
Inclusion Criteria:
- AAA with a minimum diameter of 40 mm, calculated with a standardized method
- No indication for an immediate surgery or endoprothesis implantation
- Age above 18 (except for patient under supervision)
- Patient having read the information letter and signed the informed consent
Exclusion Criteria:
- AAA should have no other specific cause than atherosclerosis
Sites / Locations
- Service de Médecine Nucléaire - CHU JEAN Minjoz
- CHU de Nancy - Hôpital Brabois
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Non surgical aneurysm of abdominal aorta
Arm Description
PET-Scan
Outcomes
Primary Outcome Measures
Association between overall baseline 18-FDG uptake intensity of the aneurysm and its 9-month maximal diameter and/or volume in patients with diameter change greater than 4 mm/year
Composite primary outcome.
Secondary Outcome Measures
Association between initial 18-FDG uptake of individual aneurysmal segments and their 9-month diameter change.
Contribution of overall 18-FDG uptake to the predictive values of other baseline characteristics of the aneurysm (diameter, volume, thickness and wall stress, clinical and biological values)
Association between overall 18-FDG uptake and other baseline characteristics of the aneurysm (diameter, volume, thickness and wall stress, clinical and biological values).
Association between 9-month overall 18-FDG uptake change and variation of plasmatic biomarkers of inflammation, proteolysis and coagulation.
Full Information
NCT ID
NCT02182908
First Posted
June 10, 2014
Last Updated
August 3, 2021
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02182908
Brief Title
FDG PET-Scan Analysis of Evolutivity of Non-surgical Aneurysm of Abdominal Aorta
Acronym
AAA
Official Title
ANALYSE EN MORPHO-TEP AU FDG DE L'EVOLUTIVITE DES ANEVRISMES ABDOMINAUX AORTIQUES NON CHIRURGICAUX UNE ETUDE MULTICENTRIQUE DE L'INTER-REGION NORD-EST
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary aim of the study is to determine if the evolutivity of global and segmentary captation of FDG-F18, which can be measured in the wall of abdominal aorta aneurysm, is predictive of the 9 month evolution of diameter and volume of the aneurysm, measured globally and segmentary in angioscan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medically-treated Aneurysm of Abdominal Aorta
Keywords
Aneurysm of abdominal aorta, 18F-fluorodesoxyglucose (FDG-F18)
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non surgical aneurysm of abdominal aorta
Arm Type
Other
Arm Description
PET-Scan
Intervention Type
Other
Intervention Name(s)
PET-Scan
Intervention Description
PET-Scan
Primary Outcome Measure Information:
Title
Association between overall baseline 18-FDG uptake intensity of the aneurysm and its 9-month maximal diameter and/or volume in patients with diameter change greater than 4 mm/year
Description
Composite primary outcome.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Association between initial 18-FDG uptake of individual aneurysmal segments and their 9-month diameter change.
Time Frame
9 months
Title
Contribution of overall 18-FDG uptake to the predictive values of other baseline characteristics of the aneurysm (diameter, volume, thickness and wall stress, clinical and biological values)
Time Frame
9 months
Title
Association between overall 18-FDG uptake and other baseline characteristics of the aneurysm (diameter, volume, thickness and wall stress, clinical and biological values).
Time Frame
9 months
Title
Association between 9-month overall 18-FDG uptake change and variation of plasmatic biomarkers of inflammation, proteolysis and coagulation.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AAA with a minimum diameter of 40 mm, calculated with a standardized method
No indication for an immediate surgery or endoprothesis implantation
Age above 18 (except for patient under supervision)
Patient having read the information letter and signed the informed consent
Exclusion Criteria:
- AAA should have no other specific cause than atherosclerosis
Facility Information:
Facility Name
Service de Médecine Nucléaire - CHU JEAN Minjoz
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
CHU de Nancy - Hôpital Brabois
City
Vandoeuvre-Lès-Nancy
ZIP/Postal Code
54500
Country
France
12. IPD Sharing Statement
Learn more about this trial
FDG PET-Scan Analysis of Evolutivity of Non-surgical Aneurysm of Abdominal Aorta
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