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

Status: Terminated
Location: See location...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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)

Locations
United States
Missouri
Washington University School of Medicine
Saint Louis
Time Frame
Start Date: 2017-08-01
Completion Date: 2020-04-30
Participants
Target number of participants: 2
Treatments
Other: 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.
Other: 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.
Other: 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.
Other: 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.
Sponsors
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov