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CCR2 AAA Pilot Study

NCT04592991 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-04-15

No results posted yet for this study

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.

Conditions

  • Abdominal Aortic Aneurysm (AAA)

Interventions

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mohamed M. Zayed, MD · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2022-04-04
Completion
2022-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04592991 on ClinicalTrials.gov