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Diagnostic and Targeted Therapy Approach for Abdominal Aortic Aneurysm

Phase < 1

Recruiting

Led By Mohamed M. Zayed, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

40 years old and above

Asymptomatic patients with known AAAs by CT angiogram (men ≥ 5.5 cm, women ≥ 5.0cm)

Must not have

Patients with Stage ≥ 4 chronic renal failure (calculated by modification of diet in renal disease eGFR equation [to minimize confounding imaging variables])

Inability to tolerate 60 minutes in a supine position with arms down at sides, as necessary for PET/CT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new approach for the diagnosis and targeted therapy of abdominal aortic aneurysm (AAA), a degenerative vascular disease which is typically asymptomatic until rupture, resulting in high mortality.

Who is the study for?

This trial is for men over 65 and women with abdominal aortic aneurysms (AAA) that are asymptomatic, measured by CT angiogram. It includes smokers and non-smokers who can follow study instructions. Non-AAA volunteers without AAA or significant atherosclerotic disease can also join. People unable to lie flat for an hour, those with unstable conditions, severe kidney failure, allergies to iodine/shellfish, pregnant/lactating women, or inflammatory diseases cannot participate.

What is being tested?

The NIH CCR2 AAA Study aims to develop new diagnostic methods and targeted treatments for AAA by studying the relationship between a radiotracer and CCR2 expression in patients with AAAs compared to those without. The study will involve imaging tests like PET/CT scans on different groups including people with AAAs and controls without it.

What are the potential side effects?

Potential side effects may include discomfort from lying still during the PET/CT scan procedure or reactions related to the contrast material used in imaging such as itching or rash if there's sensitivity; however specific side effects of the radiotracer aren't detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

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I have a large abdominal aortic aneurysm but no symptoms.

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I do not have an abdominal aortic aneurysm, confirmed by exam and ultrasound.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is severely reduced.

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I cannot lie flat for 60 minutes with my arms by my side.

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I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess imaging reproducibility of 64Cu-DOTA-ECL1i PET/CT in non-surgical AAA patients.

Assess the 64Cu-DOTA-ECL1i imaging characteristics in AAA patients undergoing open repair and non-AAA volunteers to determine the relationship between tracer uptake and molecular characterization of prospectively collected AAA tissues.

Determine the binding characteristics of 64Cu-DOTA-ECL1i in ex vivo human AAA specimens and correlate with associated histopathological features

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Radiotracer and CCR2 (Aim 2B)Experimental Treatment1 Intervention

Tissue samples obtained from an existing tissue bank as well as discarded tissue obtained from participants in this study will be examined to better understand the relationship between the levels of CCR2+ inflammatory cells and the inflammatory and clinical status of AAA, to gain insight into the importance of proinflammatory monocytes/macrophages in the development of AAA disease at the time of elective AAA repair.

Group II: Non-AAA GroupExperimental Treatment1 Intervention

10 (5 men; 5 women) participants will have a documented absence of AAA by screening ultrasound that was previously obtained as part of standard of care. A dosage range of 8-10 mCi (296-370 MBq) is planned for 64Cu-DOTA-ECL1i. A PET-certified medical professional will draw and administer the 64Cu-DOTA-ECL1i tracer. The dosage will be assayed in a dose calibrator before and after the administration.

Group III: Ex Vivo Human AAA Specimens (Aim 2A)Experimental Treatment1 Intervention

Tissue samples obtained from an existing tissue bank as well as discarded tissue obtained from participants in this study will be examined to assess the sensitivity and specificity of 64Cu-DOTA-ECL1i binding to ex vivo to human AAA specimens.

Group IV: AAA Group (Aim 3B-Reproducibility)Experimental Treatment1 Intervention

20 (10 men; 10 women) will receive a second PET/CT imaging study performed 10-14 days after the first PET/CT in order to determine the ability to reproduce the uptake results. A dosage range of 8-10 mCi (296-370 MBq) is planned for 64Cu-DOTA-ECL1i. A PET-certified medical professional will draw and administer the 64Cu-DOTA-ECL1i tracer. The dosage will be assayed in a dose calibrator before and after the administration.

Group V: AAA Group (Aim 3A)Experimental Treatment1 Intervention

40 (20 men; 20 women) participants with a diagnosis of AAA (above 40 years) will undergo a PET/CT scan prior to their scheduled surgical repair of their condition. The radiotracer, 64Cu-DOTA-ECL1i, will be injected to detect CCR2+ inflammatory cells. A dosage range of 8-10 mCi (296-370 MBq) is planned for 64Cu-DOTA-ECL1i. A PET-certified medical professional will draw and administer the 64Cu-DOTA-ECL1i tracer. The dosage will be assayed in a dose calibrator before and after the administration.

0 / 6Eligibility criteria met