CCR2 AAA Pilot Study

The Washington University

Status and phase: Terminated; Early Phase 1

Conditions: Abdominal Aortic Aneurysm (AAA)

Treatments: Diagnostic Test: AAA Group- PET-CT imaging with injection of 64Cu-DOTA-ECL1i; Diagnostic Test: Aortoiliac Occlusive Disease Group - PET-CT imaging with injection of 64Cu-DOTA-ECL1i

Study type: Interventional

Funder types: Other

Identifiers

NCT04592991

202004104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Non-Aneurysmal Patients, (Aim 2A, n=3)

Inclusion Criteria:

• Patients with aortoiliac occlusive disease causing lifestyle limiting claudication, rest pain, and/or tissue loss that requires aortofemoral bypass

Exclusion Criteria:

• Patients with aortoiliac occlusive disease, we will apply the same exclusion criteria as AAA patients.

Abdominal Aortic Aneurysm (AAA) Patients, (Aim 2B, n=5)

Inclusion Criteria:

• We will recruit asymptomatic patients with known AAAs by ultrasound, Doppler, and CT (men ≥ 5.5 cm, women ≥ 5.0cm);
• Both men and women, between the ages of 45 -75;
• With or without active tobacco use;

Exclusion Criteria:

• Inability to receive and sign informed consent;
• Has a history of hypersensitivity to contrast agent, Iopamidol (Isovue)
• 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;
• Severe claustrophobia;
• Positive pregnancy test or lactating;
• Has a history of hypersensitivity to 64Cu-DOTA-ECL1i or any of its excipients;
• Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data such as: Symptomatic/recently treated coronary disease, cancer requiring oncologic management, or autoimmune/inflammatory diseases (e.g., rheumatoid arthritis or multiple sclerosis) that are known to have increased associated expression of CCR2.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

AAA Group

Active Comparator group

Description:

Participants with AAA will undergo routine clinical evaluation of AAA including ultrasound and CT and scheduling of open surgical repair as directed by the treating physician. We will record age and tobacco use of participant. If participant has not had a renal function blood test performed within the past 90 days, we will draw approximately 2 teaspoons of blood for a creatinine test. We will also ask the participant's permission to use a contrast dye for the CT portion of the PET-CT scan. If the participant agrees we will additional questions to gauge eligibility to receive the contrast dye. If available, we would like to collect any discarded AAA tissue from the surgical procedure. This discarded tissue will be kept as part of a Washington University vascular research repository. If the participant agrees to this there will be a separate consent form to sign allowing the collection of the leftover tissue along with some information about medical history.

Treatment:

Diagnostic Test: AAA Group- PET-CT imaging with injection of 64Cu-DOTA-ECL1i

Aortoiliac Occlusive Disease Group

Active Comparator group

Description:

Participants with non-aneurysmal aortoiliac occlusive disease, will be eligible for the study based on lifestyle limiting claudication (lack of blood flow to muscles causing cramping), pain in the feet or toes at rest, and/or tissue loss (leg or foot ulcers that don't heal or gangrene) that requires aortofemoral bypass. The aortofemoral bypass is not part of this research study.

Treatment:

Diagnostic Test: Aortoiliac Occlusive Disease Group - PET-CT imaging with injection of 64Cu-DOTA-ECL1i