- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04592991
CCR2 AAA Pilot Study
Targeted Molecular Probe for Abdominal Aortic Aneurysm Imaging and Therapy
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: AAA Group
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. |
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.
|
Active Comparator: Aortoiliac Occlusive Disease Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
First in-person CCR2 molecular imaging using 64Cu-DOTA-ECL1i PET/CT in AAA patient
Time Frame: 1-2 weeks
|
Determine the background retention of 64Cu-DOTA-ECL1i in the abdominal aorta of patients with non-aneurysmal, atherosclerotic occlusive disease.
|
1-2 weeks
|
Perform 64Cu-DOTA-ECL1i PET/CT in AAA patients and correlate imaging readouts with tissue inflammatory biomarkers in patients undergoing open repair
Time Frame: 1-2 weeks prior to surgery
|
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.
|
1-2 weeks prior to surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mohamed M. Zayed, MD, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202004104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abdominal Aortic Aneurysm (AAA)
-
Medtronic CardiovascularCompletedAbdominal Aortic Aneurysms (AAA)United States
-
Vascutek Ltd.TerminatedAbdominal Aortic Aneurysms (AAA)United Kingdom, Netherlands, Switzerland, Spain, Germany, Belgium, Sweden, Canada, France, Italy, Austria, Monaco
-
EndologixRecruitingAAA | AAA - Abdominal Aortic AneurysmUnited States
-
EndologixNot yet recruitingAAA | AAA - Abdominal Aortic Aneurysm
-
Washington University School of MedicineRecruitingAbdominal Aortic Aneurysm (AAA) | No Abdominal Aortic Aneurysm (Non-AAA)United States
-
Medtronic CardiovascularRecruitingAAA - Abdominal Aortic AneurysmSpain, Germany, Portugal, Switzerland, Austria, France, Greece, Ireland, Italy, Netherlands, Russian Federation, Slovakia, Sweden, United Kingdom
-
Natasha Monzon SvendsenPhilips HealthcareCompleted
-
EndologixCompletedAbdominal Aortic Aneurysm (AAA)United States, United Kingdom, Germany, Netherlands
-
Novartis PharmaceuticalsTerminatedAbdominal Aortic Aneurysm (AAA)Denmark, United States, Netherlands, Sweden, United Kingdom
-
W.L.Gore & AssociatesRecruitingAAA - Abdominal Aortic AneurysmUnited States
Clinical Trials on AAA Group- PET-CT imaging with injection of 64Cu-DOTA-ECL1i
-
Washington University School of MedicineRecruiting
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingBreast Carcinoma | CalcificationUnited States
-
City of Hope Medical CenterActive, not recruitingAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditionsUnited States
-
Memorial Sloan Kettering Cancer CenterCompletedNeuroendocrine TumorsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)WithdrawnMetastatic Malignant Solid NeoplasmUnited States
-
University Hospital, CaenCompletedSquamous Cell Carcinoma of the Head and NeckFrance
-
Radboud University Medical CenterDutch Cancer SocietyUnknownNeoplasms | Carcinoma | Colorectal Cancer | Gastrointestinal Cancer | Peritoneal CarcinomatosisNetherlands
-
GlaxoSmithKlineQuintiles, Inc.CompletedAutoimmune DiseasesUnited Kingdom
-
Turku University HospitalRecruitingHypoxia | Fallopian Tube Cancer | Epithelial Ovarian Cancer | Peritoneal CarcinomaFinland
-
Scott McnallyAmerican Heart AssociationActive, not recruitingInflammation | Cognitive Impairment | Carotid Artery PlaqueUnited States