Ignite Creation Date:
2024-05-06 @ 10:21 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03231397
Status:
TERMINATED
Last Update Posted:
2021-07-09
First Post:
2017-06-22
Brief Title:
Predictors of AAA Expansion andor Rupture
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Noninvasive Assessment of Abdominal Aortic Aneurysm AAA Wall Structural Integrity and Inflammation as Predictors of Expansion andor Rupture
Status:
TERMINATED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We were unable to recruit more subjects who met the inclusionexclusion criteria and we have closed the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Eligible subjects in this study will have either a known abdominal aortic aneurysm AAA or because they do not have an AAA control group
The purpose of this research study is to further study through FEA changes that occur in the mechanical properties of the aortic wall The investigator will compare two radiotracers 18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about inflammation 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging during the PET-CT scan The investigator will also compare the results describing the mechanical properties of the AAA wall to the degree of inflammation in that wall as determined by PET-CT imaging to define new and better predictors of AAA growth andor rupture
The purpose of this research study is to further study through FEA changes that occur in the mechanical properties of the aortic wall The investigator will compare two radiotracers 18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about inflammation 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging during the PET-CT scan The investigator will also compare the results describing the mechanical properties of the AAA wall to the degree of inflammation in that wall as determined by PET-CT imaging to define new and better predictors of AAA growth andor rupture
Detailed Description:
Eligible subjects in this study will have either a known abdominal aortic aneurysm AAA or because they do not have an AAA control group
The aorta serves as the main artery to supply blood flow to the body It is approximately the size of a garden hose Due to the effects of high blood pressure hypertension atherosclerosis hardening of the arteries and tobacco use the aorta may widen and enlarge to form an aneurysm An abdominal aortic aneurysm AAA is a dilation enlargement or ballooning out of a section of blood vessel caused by disease or weakness in the wall of the aorta below the level of the kidney arteries As an AAA dilates and increases in size rupture of the AAA may occur AAA rupture carries a significant risk of death
Currently aortic size is the primary factor used to assess aortic rupture risk There are other imaging procedures imaging modalities that are being used and developed to assess AAA rupture risk Finite element analysis FEA is a way to study the mechanical properties of the aortic wall including areas of stress and strength that are used to calculate rupture risk Positron Emission Tomography PET utilizes glucose a form of sugar labeled with a radioactivity to look at the metabolic activity and inflammation in the aortic wall
The purpose of this research study is to further study through FEA changes that occur in the mechanical properties of the aortic wall The investigator will compare two radiotracers 18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about inflammation 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging during the PET-CT scan The investigator will also compare the results describing the mechanical properties of the AAA wall to the degree of inflammation in that wall as determined by PET-CT imaging to define new and better predictors of AAA growth andor rupture
The radioactive tracers that are used in this study are 18F-fludeoxyglucose FDG and 11C-PBR28 PBR which stands for Peripheral Benzodiazepine Receptor 11C-PBR28 is considered investigational which means that it has not been approved by the US Food and Drug Administration FDG is an approved drug by the FDA however in this study it is considered investigational
Goal Twenty-four subjects will be recruited for this study Six control subjects three males and three females will be considered Control subjects will have known atherosclerosis without aneurysmal disease Six subjects three males and three females with small AAAs diameter 30-45cm six subjects three males AAA 55cm and three females AAA 50cm with AAAs that are indicated for treatment and six subjects three males and three females with rapidly expanding AAAs 05cm over 6 months andor 10cm over 12 months will be considered
Subjects will have blood drawn to perform a genetic test that will look at genes and proteins to determine subject eligibility Once the blood work is assessed for eligibility subjects will undergo the PET-CT scan The imaging will take approximately 3 hours to complete
The aorta serves as the main artery to supply blood flow to the body It is approximately the size of a garden hose Due to the effects of high blood pressure hypertension atherosclerosis hardening of the arteries and tobacco use the aorta may widen and enlarge to form an aneurysm An abdominal aortic aneurysm AAA is a dilation enlargement or ballooning out of a section of blood vessel caused by disease or weakness in the wall of the aorta below the level of the kidney arteries As an AAA dilates and increases in size rupture of the AAA may occur AAA rupture carries a significant risk of death
Currently aortic size is the primary factor used to assess aortic rupture risk There are other imaging procedures imaging modalities that are being used and developed to assess AAA rupture risk Finite element analysis FEA is a way to study the mechanical properties of the aortic wall including areas of stress and strength that are used to calculate rupture risk Positron Emission Tomography PET utilizes glucose a form of sugar labeled with a radioactivity to look at the metabolic activity and inflammation in the aortic wall
The purpose of this research study is to further study through FEA changes that occur in the mechanical properties of the aortic wall The investigator will compare two radiotracers 18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about inflammation 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging during the PET-CT scan The investigator will also compare the results describing the mechanical properties of the AAA wall to the degree of inflammation in that wall as determined by PET-CT imaging to define new and better predictors of AAA growth andor rupture
The radioactive tracers that are used in this study are 18F-fludeoxyglucose FDG and 11C-PBR28 PBR which stands for Peripheral Benzodiazepine Receptor 11C-PBR28 is considered investigational which means that it has not been approved by the US Food and Drug Administration FDG is an approved drug by the FDA however in this study it is considered investigational
Goal Twenty-four subjects will be recruited for this study Six control subjects three males and three females will be considered Control subjects will have known atherosclerosis without aneurysmal disease Six subjects three males and three females with small AAAs diameter 30-45cm six subjects three males AAA 55cm and three females AAA 50cm with AAAs that are indicated for treatment and six subjects three males and three females with rapidly expanding AAAs 05cm over 6 months andor 10cm over 12 months will be considered
Subjects will have blood drawn to perform a genetic test that will look at genes and proteins to determine subject eligibility Once the blood work is assessed for eligibility subjects will undergo the PET-CT scan The imaging will take approximately 3 hours to complete
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None