NCT04592991

CCR2 AAA Pilot Study

Targeted Molecular Probe for Abdominal Aortic Aneurysm Imaging and Therapy

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to look at whether an investigational imaging agent, 64Cu-DOTA-ECL1i, used during Positron Emission Tomography (PET)/ Computed Tomography (CT) scanning, can help to identify conditions that place patients at an increased risk for AAA rupture. The study is also looking more closely at cellular, molecular and inflammatory properties of the aortic wall. Having the ability to identify markers that predict AAA progression/expansion and risk for rupture could allow the physician to manage patients in a more individualized, personal way.

Detailed description

Abdominal aortic aneurysm (AAA) is a life-threatening degenerative vascular disease characterized by transmural aortic macrophage infiltration, elastin degradation, and reduction of smooth muscle cell content. AAAs occurs later in life and are especially prevalent in men over the age of 65. Patients typically remain asymptomatic until rupture, which is associated with high mortality. Currently, surgical repair is the only approach for AAA treatment, and there is no pharmacological intervention. Clinically, ultrasound and computed tomography measurement of aneurysm diameter represents the mainstay of management and the principal determinant of timing for elective surgical repair. However, this anatomy-based approach fails to provide useful information about the cellular and molecular processes associated with aneurysm expansion and rupture. Therefore, developing translatable molecular biomarkers, specifically expressed by aneurysms, is necessary to determine associated status and progression, capture the risk of rupture, and deliver personalized treatment.

Conditions

• Abdominal Aortic Aneurysm (AAA)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Aortoiliac Occlusive Disease Group - PET-CT imaging with injection of 64Cu-DOTA-ECL1i	Patients from both genders, all ethnic groups, and between the ages of 45 and 75 will be considered for recruitment. We will recruit patients who have evidence of abdominal aortic aneurysm (AAA) as our study patient cohort. Patients with non-aneurysmal, atherosclerotic aortoiliac occlusive disease (n=3) will be enrolled in Aim 2A and undergo Cu-64 DOTA-ECL1i PET/CT.
DIAGNOSTIC_TEST	AAA Group- PET-CT imaging with injection of 64Cu-DOTA-ECL1i	Patients from both genders, all ethnic groups, and between the ages of 45 and 75 will be considered for recruitment. We will recruit patients who have evidence of abdominal aortic aneurysm (AAA) as our study patient cohort. Patients with Abdominal aortic aneurysm (AAA) (n=5) will be enrolled in Aim 2B and undergo Cu-64 DOTA-ECL1i PET/CT and contrast-enhanced CT angiography between 7-14 days of their scheduled elective open repair surgery.

Timeline

• Start date: 2020-10-07
• Primary completion: 2022-04-04
• Completion: 2022-04-04
• First posted: 2020-10-19
• Last updated: 2022-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study