Predictors of AAA Expansion and/or Rupture

NCT03231397 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 201702141
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm (AAA)

Keywords

Abdominal Aortic Aneurysm (AAA)

Outcome Measures

Primary Outcomes (1)

• Standard Uptake Value (SUV)

  Aortic inflammation as demonstrated by uptake of radiotracer

  1 day

Secondary Outcomes (2)

• Rupture Potential Index (RPI)

  9-10 months

• Qualitative Comparison of SUV and RPI

  9-10 months

Study Arms (4)

Control Group

OTHER

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; Drug: 18F-fludeoxyglucose (FDG); Diagnostic Test: 11C-PBR28

Small AAA's

OTHER

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; Drug: 18F-fludeoxyglucose (FDG); Diagnostic Test: 11C-PBR28

Rapidly expanding AAA's

OTHER

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; Drug: 18F-fludeoxyglucose (FDG); Diagnostic Test: 11C-PBR28

AAA's undergoing treatment

OTHER

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; Drug: 18F-fludeoxyglucose (FDG); Diagnostic Test: 11C-PBR28

Interventions

Assess AAA rupture risk by PET-CTA scans DRUG

Assess AAA rupture risk by PET-CTA scans

AAA's undergoing treatment; Control Group; Rapidly expanding AAA's; Small AAA's

18F-fludeoxyglucose (FDG) DRUG

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

Also known as: 18F-FDG

AAA's undergoing treatment; Control Group; Rapidly expanding AAA's; Small AAA's

11C-PBR28 DIAGNOSTIC_TEST

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; Control Group; Rapidly expanding AAA's; Small AAA's

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All ethnic groups
• 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)

You may not qualify if:

• At risk population (cognitively impaired)
• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Results Point of Contact

• Title: Dr. Sean J. English
• Organization: Washington University School of Medicine

sjenglish@wustl.edu

(314) 362-5707

Study Officials

• Sean J. English, MD

  Washington University School of Medicine, St. Louis, MO 63110

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 27, 2017
• Study Start: August 1, 2017
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: July 9, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)