Trial Outcomes & Findings for Predictors of AAA Expansion and/or Rupture (NCT NCT03231397)

NCT ID: NCT03231397

Last Updated: 2021-07-09

Results Overview

Aortic inflammation as demonstrated by uptake of radiotracer

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

1 day

Results posted on

2021-07-09

Participant Flow

The plan was to enroll 30 subjects, however, due to the lack of willing participants, we were only able to enroll 2 subjects.

Participant milestones

Participant milestones
Measure	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. Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans 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 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. Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans 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 11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predictors of AAA Expansion and/or Rupture

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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. Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans 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 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 n=1 Participants 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. Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans 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 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 n=1 Participants 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. Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans 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 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. Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans 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 11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Age, Categorical >=65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants	—	2 Participants n=21 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants	—	2 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) White	—	1 Participants n=7 Participants	1 Participants n=5 Participants	—	2 Participants n=21 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants	—	2 participants n=21 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Recruitment was difficult. We enrolled 1 subject with a small AAA and 1 subject with a rapidly expanding AAA, however, we were unable to recruit the number of subjects in each category to provide meaningful outcomes.

Aortic inflammation as demonstrated by uptake of radiotracer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9-10 months

Rupture potential index (RPI) is defined as the ratio of the acting wall stress to the wall strength, and the maximum RPI for AAA represents its rupture risk. Currently, the primary factor considered for risk of human AAA rupture is aortic diameter; however, it is well documented that small AAAs (\<5cm) rupture, while many large AAAs (\>8cm) are incidentally discovered. We will assess the ability of imaging techniques to determine abdominal aortic aneurysm (AAA) rupture risk individually and in concert.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9-10 months

Population: Because recruitment goals were not met, this computerized numerical method was not completed. We were only able to enroll 2 subjects.

Finite element analysis (FEA) is a computerized numerical method used for the prediction of how the aorta may behave under stress. This software will be used to assess the same aortic volume comparing areas of greatest stress and lowest strength. Co-registration of images obtained by different imaging modalities will allow for comparison between imaging modalities. With direct co-registration of the data sets for each subject, qualitative comparisons will be made regarding areas of 18F-FDG and 11C-PBR28 uptake, as well as stress, strength, and RPI.

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Small AAA's

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Rapidly Expanding AAA's

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

AAA's Undergoing Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sean J. English

Washington University School of Medicine

Phone: (314) 362-5707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place