Predictors of AAA Expansion and/or Rupture

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Abdominal aortic aneurysm
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Brief Title

Predictors of AAA Expansion and/or Rupture

Official Title

Noninvasive Assessment of Abdominal Aortic Aneurysm (AAA) Wall Structural Integrity and Inflammation as Predictors of Expansion and/or Rupture

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.

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Standard uptake value (SUV)

Secondary Outcome

 Rupture potential index (RPI)

Condition

Abdominal Aortic Aneurysm (AAA)

Intervention

Assess AAA rupture risk by PET-CTA scans

Study Arms / Comparison Groups

 Control Group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

30

Start Date

August 1, 2017

Completion Date

April 30, 2020

Primary Completion Date

April 30, 2020

Eligibility 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

Gender

All

Ages

45 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sean J. English, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03231397

Organization ID

201702141

Responsible Party

Sponsor

Study Sponsor

Washington University School of Medicine

Study Sponsor

Sean J. English, MD, Principal Investigator, Washington University School of Medicine, St. Louis, MO 63110

Verification Date

May 2020