FDG PET-Scan Analysis of Evolutivity of Non-surgical Aneurysm of Abdominal Aorta
AAA
ANALYSE EN MORPHO-TEP AU FDG DE L'EVOLUTIVITE DES ANEVRISMES ABDOMINAUX AORTIQUES NON CHIRURGICAUX UNE ETUDE MULTICENTRIQUE DE L'INTER-REGION NORD-EST
1 other identifier
interventional
51
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2007
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
July 8, 2014
CompletedAugust 5, 2021
July 1, 2021
6.2 years
June 10, 2014
August 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
9 months
Secondary Outcomes (4)
Association between initial 18-FDG uptake of individual aneurysmal segments and their 9-month diameter change.
9 months
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)
9 months
Association between overall 18-FDG uptake and other baseline characteristics of the aneurysm (diameter, volume, thickness and wall stress, clinical and biological values).
9 months
Association between 9-month overall 18-FDG uptake change and variation of plasmatic biomarkers of inflammation, proteolysis and coagulation.
9 months
Study Arms (1)
Non surgical aneurysm of abdominal aorta
OTHERPET-Scan
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- AAA should have no other specific cause than atherosclerosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Service de Médecine Nucléaire - CHU JEAN Minjoz
Besançon, 25000, France
CHU de Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2014
First Posted
July 8, 2014
Study Start
March 1, 2007
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
August 5, 2021
Record last verified: 2021-07