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Predictors of AAA Expansion and/or Rupture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03231397
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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 and/or rupture.


Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm (AAA) Drug: Assess AAA rupture risk by PET-CTA scans Drug: 18F-fludeoxyglucose (FDG) Diagnostic Test: 11C-PBR28 Phase 4

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 and/or 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 U.S. 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 3.0-4.5cm), six subjects (three males, AAA >5.5cm and three females, AAA >5.0cm) with AAAs that are indicated for treatment, and six subjects (three males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model 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 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 and/or rupture.

Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Noninvasive Assessment of Abdominal Aortic Aneurysm (AAA) Wall Structural Integrity and Inflammation as Predictors of Expansion and/or Rupture
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control Group

Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.

To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.

Drug: Assess AAA rupture risk by PET-CTA scans
Assess AAA rupture risk by PET-CTA scans

Drug: 18F-fludeoxyglucose (FDG)
Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging
Other Name: 18F-FDG

Diagnostic Test: 11C-PBR28
Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging

Small AAA's

Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).

To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.

Drug: Assess AAA rupture risk by PET-CTA scans
Assess AAA rupture risk by PET-CTA scans

Drug: 18F-fludeoxyglucose (FDG)
Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging
Other Name: 18F-FDG

Diagnostic Test: 11C-PBR28
Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging

Rapidly expanding AAA's

Six subjects (three males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm over 12 months).

To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.

Drug: Assess AAA rupture risk by PET-CTA scans
Assess AAA rupture risk by PET-CTA scans

Drug: 18F-fludeoxyglucose (FDG)
Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging
Other Name: 18F-FDG

Diagnostic Test: 11C-PBR28
Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging

AAA's undergoing treatment

Six subjects (three males, AAA >5.5cm and three females, AAA >5.0cm) with AAAs that are indicated for treatment.

To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.

Drug: Assess AAA rupture risk by PET-CTA scans
Assess AAA rupture risk by PET-CTA scans

Drug: 18F-fludeoxyglucose (FDG)
Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging
Other Name: 18F-FDG

Diagnostic Test: 11C-PBR28
Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging




Primary Outcome Measures :
  1. Standard uptake value (SUV) [ Time Frame: 1-8 months ]
    Aortic inflammation as demonstrated by uptake of radiotracer


Secondary Outcome Measures :
  1. Rupture potential index (RPI) [ Time Frame: 9-10 months ]
    Aortic wall mechanical instability

  2. Qualitative comparison of SUV and RPI [ Time Frame: 9-10 months ]
    Comparison of aortic inflammation and mechanical instability

  3. Data analysis and abstract submission for publication [ Time Frame: 11-12 months ]
    There will be experimental and control group analysis by comparing subject demographics and aortic image measures. ANOVA with post hoc analyses will be performed to compare the groups.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • All ethnic groups
  • 45 years of age or older
  • *Must fit into one of the three following groups:

    • Control group (atherosclerosis without aneurysmal disease
    • Small AAA (3-4.5 cm)
    • Rapidly growing AAA (0.5 cm in 6 months or 1 cm in 12 months)

Exclusion

  • At risk population (cognitively impaired)
  • Any exclusion for PT-CT (i.e., allergy to contrast)
  • Any woman planning to become pregnant, suspects pregnancy, pregnant or breastfeeding)
  • Any greater than normal potential for cardiac arrest
  • Renal disease (eGFR <60 mg/ml/1.73m2)
  • Claustrophobic reactions and/or is unable to lie on the exam table for 60 minutes
  • Significant radiation exposure via other trials or medical testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231397


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Sean J. English, MD Washington University School of Medicine, St. Louis, MO 63110
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03231397    
Other Study ID Numbers: 201702141
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Washington University School of Medicine:
Abdominal Aortic Aneurysm (AAA)
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Rupture
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action