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Completed

NCT Number: NCT02182908

FDG PET-Scan Analysis of Evolutivity of Non-surgical Aneurysm of Abdominal Aorta

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.

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Key information

Conditions

Medically-treated Aneurysm of Abdominal Aorta Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Médecine Nucléaire - CHU JEAN Minjoz, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET-scan

Other

PET-Scan

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

    Time frame: 9 months

    Composite primary outcome.

Secondary outcomes

  1. Association between initial 18-FDG uptake of individual aneurysmal segments and their 9-month diameter change.

    Time frame: 9 months

  2. 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

  3. 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

  4. Association between 9-month overall 18-FDG uptake change and variation of plasmatic biomarkers of inflammation, proteolysis and coagulation.

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Acronym: AAA

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jul 8, 2014
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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