CCR2 AAA Pilot Study

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 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

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