Back to resultsCCR2 AAA Pilot Study
Primary Purpose
Abdominal Aortic Aneurysm (AAA)
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aortoiliac Occlusive Disease Group - PET-CT imaging with injection of 64Cu-DOTA-ECL1i
AAA Group- PET-CT imaging with injection of 64Cu-DOTA-ECL1i
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Aortic Aneurysm (AAA)
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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
AAA Group
Aortoiliac Occlusive Disease Group
Arm 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.
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.
Outcomes
Primary Outcome Measures
First in-person CCR2 molecular imaging using 64Cu-DOTA-ECL1i PET/CT in AAA patient
Determine the background retention of 64Cu-DOTA-ECL1i in the abdominal aorta of patients with non-aneurysmal, atherosclerotic occlusive disease.
Perform 64Cu-DOTA-ECL1i PET/CT in AAA patients and correlate imaging readouts with tissue inflammatory biomarkers in patients undergoing open repair
Patients undergoing open AAA repair will be scheduled for PET/CT imaging at 1-2 weeks prior to surgery. This will be first-in-patient molecular imaging using CCR2 targeted 64Cu-DOTA-ECL1i in AAA patients undergoing open repair. The surgically removed aneurysmal tissue will be collected and processed for a complete characterization.
Secondary Outcome Measures
Full Information
NCT ID
NCT04592991
First Posted
October 5, 2020
Last Updated
April 9, 2022
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04592991
Brief Title
CCR2 AAA Pilot Study
Official Title
Targeted Molecular Probe for Abdominal Aortic Aneurysm Imaging and Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
We were only able to enroll 1 subject so we had no way to compare a control or other study groups and develop any kind of results. This study is essentially the same study as NCT04586452, which we would like to place focus and effort on that study.
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm (AAA)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Model Description
There will be two (2) groups in this study. We plan to recruit 5 patients with AAA and 3 patients with diagnosed non-aneurysmal (without aneurysm) aortoiliac occlusive disease.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AAA Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Aortoiliac Occlusive Disease Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Aortoiliac Occlusive Disease Group - PET-CT imaging with injection of 64Cu-DOTA-ECL1i
Intervention Description
Patients from both genders, all ethnic groups, and between the ages of 45 and 75 will be considered for recruitment. We will recruit patients who have evidence of abdominal aortic aneurysm (AAA) as our study patient cohort. Patients with non-aneurysmal, atherosclerotic aortoiliac occlusive disease (n=3) will be enrolled in Aim 2A and undergo Cu-64 DOTA-ECL1i PET/CT.
Intervention Type
Diagnostic Test
Intervention Name(s)
AAA Group- PET-CT imaging with injection of 64Cu-DOTA-ECL1i
Intervention Description
Patients from both genders, all ethnic groups, and between the ages of 45 and 75 will be considered for recruitment. We will recruit patients who have evidence of abdominal aortic aneurysm (AAA) as our study patient cohort. Patients with Abdominal aortic aneurysm (AAA) (n=5) will be enrolled in Aim 2B and undergo Cu-64 DOTA-ECL1i PET/CT and contrast-enhanced CT angiography between 7-14 days of their scheduled elective open repair surgery.
Primary Outcome Measure Information:
Title
First in-person CCR2 molecular imaging using 64Cu-DOTA-ECL1i PET/CT in AAA patient
Description
Determine the background retention of 64Cu-DOTA-ECL1i in the abdominal aorta of patients with non-aneurysmal, atherosclerotic occlusive disease.
Time Frame
1-2 weeks
Title
Perform 64Cu-DOTA-ECL1i PET/CT in AAA patients and correlate imaging readouts with tissue inflammatory biomarkers in patients undergoing open repair
Description
Patients undergoing open AAA repair will be scheduled for PET/CT imaging at 1-2 weeks prior to surgery. This will be first-in-patient molecular imaging using CCR2 targeted 64Cu-DOTA-ECL1i in AAA patients undergoing open repair. The surgically removed aneurysmal tissue will be collected and processed for a complete characterization.
Time Frame
1-2 weeks prior to surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M. Zayed, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CCR2 AAA Pilot Study
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