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Diagnostic and Targeted Therapy Approach for Abdominal Aortic Aneurysm

Q: Is this research accommodating participants who are older than 25 years of age?

As per the study's eligibility requirements, applicants must be between 40 and 80 years of age.

Q: What is the cap for participation in this experimental undertaking?

Affirmative, the information on clinicaltrials.gov corroborates that this trial is currently enrolling participants. It was first made visible to the public on February 17th 2021 and its last update came July 11th 2022. A total of 50 volunteers are sought from a single research site.

Q: Are there still opportunities to participate in this experiment?

Affirmative. The information located on clinicaltrials.gov implies that this study is actively seeking participants with the first posting occurring February 17th 2021 and the most recent update being July 11th 2022. 50 patients are needed from 1 centre.

Q: May I submit my candidacy for this clinical experiment?

This clinical trial seeks fifty participants between 40 and 80 years of age who have aneurysm. Additional requirements include being above the age of forty, having or not having active tobacco use, patients with known AAAs by CT angiogram (men ≥ 5.5 cm, women ≥ 5.0cm), exhibiting willingness to follow protocol instructions for study procedures, as well as non-AAA volunteers that can provide a documented absence of AAA via exam and recent screening ultrasound (US).

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,936 Previous Clinical Trials

2,299,802 Total Patients Enrolled

Mohamed M. Zayed, MDPrincipal InvestigatorWashington University of Medicine

1 Previous Clinical Trials

1 Total Patients Enrolled

Media Library

AAA Group (Aim 3A) Clinical Trial Eligibility Overview. Trial Name: NCT04586452 — Phase < 1

Abdominal Aortic Aneurysm Research Study Groups: Ex Vivo Human AAA Specimens (Aim 2A), AAA Group (Aim 3B-Reproducibility), Non-AAA Group, AAA Group (Aim 3A), Radiotracer and CCR2 (Aim 2B)

Abdominal Aortic Aneurysm Clinical Trial 2023: AAA Group (Aim 3A) Highlights & Side Effects. Trial Name: NCT04586452 — Phase < 1

AAA Group (Aim 3A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04586452 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research accommodating participants who are older than 25 years of age?

"As per the study's eligibility requirements, applicants must be between 40 and 80 years of age."

Answered by AI

What is the cap for participation in this experimental undertaking?

"Affirmative, the information on clinicaltrials.gov corroborates that this trial is currently enrolling participants. It was first made visible to the public on February 17th 2021 and its last update came July 11th 2022. A total of 50 volunteers are sought from a single research site."

Answered by AI

Are there still opportunities to participate in this experiment?

"Affirmative. The information located on clinicaltrials.gov implies that this study is actively seeking participants with the first posting occurring February 17th 2021 and the most recent update being July 11th 2022. 50 patients are needed from 1 centre."

Answered by AI

May I submit my candidacy for this clinical experiment?

"This clinical trial seeks fifty participants between 40 and 80 years of age who have aneurysm. Additional requirements include being above the age of forty, having or not having active tobacco use, patients with known AAAs by CT angiogram (men ≥ 5.5 cm, women ≥ 5.0cm), exhibiting willingness to follow protocol instructions for study procedures, as well as non-AAA volunteers that can provide a documented absence of AAA via exam and recent screening ultrasound (US)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NIH CCR2 AAA Study

2021. "NIH CCR2 AAA Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04586452.

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