PET Detection of CCR2 in Human Atherosclerosis
1 other identifier
interventional
100
1 country
1
Brief Summary
: Use of novel radio-pharmaceutical 64CUDOTA-ECL1i to evaluate arterial atherosclrosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2020
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2020
CompletedFirst Posted
Study publicly available on registry
September 3, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedAugust 1, 2025
July 1, 2025
4.9 years
August 17, 2020
July 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of 64CU-ECL1i , imaging characteristics
Injecting normal volunteers and patients who have blocked arteries with a single bolus injection. The dose of the injection is 8-10, and the above drug is measured in millicuries, which is a unit of radioactivity. the dose of millicuries will be 8-10 millicures
1 or 2 days
Secondary Outcomes (1)
PET/MR camera, imaging performance
1-2 days
Study Arms (2)
Aim 1A
EXPERIMENTALNormal volunteers and patients with Carotid and Femoral Atherosclerosis who will be having surgery
Aim 1B
EXPERIMENTALPatients with Carotid and Femoral Atherosclerosis who will be managed medically and not having surgery
Interventions
Patients in Group 1, normal volunteers and patients with carotid and femoral artery disease who will be having surgery, will have a 1 day imaging session lasting approximately 60 minutes with an injection of 64CU-DOTA-ECL1i to visualize the carotid and femoral arteries. Patients with carotid and femoral artery disease will have their plaque specimens collected for further sutdy
Patients in Group 2, who are patients with carotid and femoral artery disease who will not be having surgery will have two imaging sessions 7-14 days apart
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University CCIR
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2020
First Posted
September 3, 2020
Study Start
October 1, 2020
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
August 1, 2025
Record last verified: 2025-07