Brief Title
CCR2 AAA Pilot Study
Official Title
Targeted Molecular Probe for Abdominal Aortic Aneurysm Imaging and Therapy
Brief 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.
Detailed 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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
First in-person CCR2 molecular imaging using 64Cu-DOTA-ECL1i PET/CT in AAA patient
Condition
Abdominal Aortic Aneurysm (AAA)
Intervention
Aortoiliac Occlusive Disease Group - PET-CT imaging with injection of 64Cu-DOTA-ECL1i
Study Arms / Comparison Groups
AAA 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
1
Start Date
October 7, 2020
Completion Date
April 4, 2022
Primary Completion Date
April 4, 2022
Eligibility 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.
Gender
All
Ages
45 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Mohamed M. Zayed, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04592991
Organization ID
202004104
Responsible Party
Sponsor
Study Sponsor
Washington University School of Medicine
Study Sponsor
Mohamed M. Zayed, MD, Principal Investigator, Washington University School of Medicine
Verification Date
April 2022