AAA: FDG PET-Scan Analysis of Evolutivity of Non-surgical Aneurysm of Abdominal Aorta
Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT02182908
Collaborator
(none)
51
2
1
74
25.5
0.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
51 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
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 Start Date
:
Mar 1, 2007
Actual Primary Completion Date
:
May 1, 2013
Actual Study Completion Date
:
May 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Non surgical aneurysm of abdominal aorta PET-Scan |
Other: PET-Scan
PET-Scan
|
Outcome Measures
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 [9 months]
Composite primary outcome.
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de Médecine Nucléaire - CHU JEAN Minjoz | Besançon | France | 25000 | |
| 2 | CHU de Nancy - Hôpital Brabois | Vandoeuvre-Lès-Nancy | France | 54500 |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT02182908
Other Study ID Numbers:
- 2006-004852-19
First Posted:
Jul 8, 2014
Last Update Posted:
Aug 5, 2021
Last Verified:
Jul 1, 2021
Keywords provided by Central Hospital, Nancy, France
Additional relevant MeSH terms: