NCT04586452

NIH CCR2 AAA Study

Completed EARLY_PHASE1 Last updated 15 July 2025

What this trial tests

EARLY_PHASE1 trial testing AAA Group (Aim 3A) in Abdominal Aortic Aneurysm (AAA) in 50 participants. Completed in 4 April 2022.

Timeline

17 February 2021

Primary endpoint
4 April 2022

4 April 2022

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	50
Start date	17 February 2021
Primary completion	4 April 2022
Estimated completion	4 April 2022
Sites	1 location across United States

Drugs / interventions tested

• AAA Group (Aim 3A)
• Non-AAA Group
• Ex Vivo Human AAA Specimens (Aim 2A)
• Relationship between radiotracer and CCR2 (Aim 2B)
• AAA Group (Aim 3B-Reproducibility)

Conditions studied

• Abdominal Aortic Aneurysm (AAA) — all drugs for Abdominal Aortic Aneurysm (AAA) →
• No Abdominal Aortic Aneurysm (Non-AAA) — all drugs for No Abdominal Aortic Aneurysm (Non-AAA) →

Sponsor

Washington University School of Medicine

Who can join

40 and older, any sex, with Abdominal Aortic Aneurysm (AAA) or No Abdominal Aortic Aneurysm (Non-AAA). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Abdominal aortic aneurysm (AAA) is a degenerative vascular disease, which is typically asymptomatic until rupture, resulting in high mortality. AAAs are more prevalent in men over age 65, though rupture is disproportionately higher in women. Due to nonlinear and unpredictable aortic dilatation, it is challenging to predict the AAA rupture using clinical diagnostics based on morphology. No medical therapy is used clinically to treat AAA, and there is an unmet need for clinically translatable, molecular biomarkers of AAA disease activity for surveillance and patient-specific management. The goal of this proposal is to develop a new approach for the diagnosis and targeted therapy of AAA.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel PET Imaging of Inflammatory Targets and Cells for the Diagnosis and Monitoring of Giant Cell Arteritis and Polymyalgia Rheumatica.
   van der Geest KSM, Sandovici M, Nienhuis PH, Slart RHJA, et al · · 2022 · cited 21× · PMID 35733858 · DOI 10.3389/fmed.2022.902155
2. Chemokine Receptor 2 Is a Theranostic Biomarker for Abdominal Aortic Aneurysms.
   Elizondo-Benedetto S, Sastriques-Dunlop S, Detering L, Arif B, et al · · 2025 · cited 8× · PMID 40272356 · DOI 10.1016/j.jacbts.2025.02.010
3. Chemokine receptor PET imaging: Bridging molecular insights with clinical applications.
   Hunter C, Larimer B. · · 2024 · cited 2× · PMID 38691942 · DOI 10.1016/j.nucmedbio.2024.108912
4. Pilot first-in-human CCR2 PET/CT to detect abdominal aortic aneurysm wall instability.
   Elizondo-Benedetto S, Sultan D, Wahidi R, Hamdi M, et al · · 2025 · cited 1× · PMID 40365294 · DOI 10.7150/thno.108656
5. <i>CopperNostics</i>-Here We Are Now, Entertain Us!
   Brühlmann SA, Walther M, Kopka K, Kreller M, et al · · 2026 · PMID 41754861 · DOI 10.3390/ph19020321