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PET Detection of CCR2 in Human Atherosclerosis

Primary Purpose

Carotid Atherosclerosis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine)
Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carotid Atherosclerosis

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Normal Volunteers: 18-40 years of age, non smoker, no history of diabetes, hypertension, or hyperlipidemia. Patients: 50-89 years of age, adequate nutritional status, with or without smoking history, diabetes, hypertension, and hyperlipidema. Both asymptomatic and symptomatic patients with known carotid artery atherosclrosis >70% and scheduled to undergo surgery. Advanced peripheral artery disease.

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Exclusion Criteria:Inability to receive and sign informed consent. Currently enrolled in another study. Patients who have type 1 diabetes or are in septic shock, receiving steroid therapy, recent history of heavy alcohol consumption, (male >2 drinks per day, and female > 1 drink per day. following extreme diets like Atkins or South Beach diet or with Stage 4 chronic renal failure. Patients with unstable clinical condition that in the opinion of the PI precludes participation in the study. Inability to tolerate 60 minutes in a supine position with arms down at sides. Contraindications to MR imaging, (pacemaker, brain aneurysm clips, shrapnel, etc. Positive pregnancy test or lactating. Have another conditions such as cancer or autoimmune/inflammatory diseases, e.g. rheumatoid arthritis or multiple sclerosis that are known to have increased expression of CCR2.

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Sites / Locations

  • Washington University CCIRRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aim 1A

Aim 1B

Arm Description

Normal volunteers and patients with Carotid and Femoral Atherosclerosis who will be having surgery

Patients with Carotid and Femoral Atherosclerosis who will be managed medically and not having surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PET/MR camera, imaging performance
Utilizing the PET/MR camera using audiography, which can show the presence and size of the blockage

Full Information

First Posted
August 17, 2020
Last Updated
November 29, 2021
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04537403
Brief Title
PET Detection of CCR2 in Human Atherosclerosis
Official Title
PET Detection of CCR2 in Human Atherosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

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

5. Study Description

Brief Summary
: Use of novel radio-pharmaceutical 64CUDOTA-ECL1i to evaluate arterial atherosclrosis
Detailed Description
Using 64CUDOTA-ECL1i to evaluate arterial atherosclrosis in normal volunteers and patients with carotid or femoral arterial atherosclerosis..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Atherosclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aim 1A
Arm Type
Experimental
Arm Description
Normal volunteers and patients with Carotid and Femoral Atherosclerosis who will be having surgery
Arm Title
Aim 1B
Arm Type
Experimental
Arm Description
Patients with Carotid and Femoral Atherosclerosis who will be managed medically and not having surgery
Intervention Type
Drug
Intervention Name(s)
Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of 64CU-ECL1i , imaging characteristics
Description
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
Time Frame
1 or 2 days
Secondary Outcome Measure Information:
Title
PET/MR camera, imaging performance
Description
Utilizing the PET/MR camera using audiography, which can show the presence and size of the blockage
Time Frame
1-2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal Volunteers: 18-40 years of age, non smoker, no history of diabetes, hypertension, or hyperlipidemia. Patients: 50-89 years of age, adequate nutritional status, with or without smoking history, diabetes, hypertension, and hyperlipidema. Both asymptomatic and symptomatic patients with known carotid artery atherosclrosis >70% and scheduled to undergo surgery. Advanced peripheral artery disease. - Exclusion Criteria:Inability to receive and sign informed consent. Currently enrolled in another study. Patients who have type 1 diabetes or are in septic shock, receiving steroid therapy, recent history of heavy alcohol consumption, (male >2 drinks per day, and female > 1 drink per day. following extreme diets like Atkins or South Beach diet or with Stage 4 chronic renal failure. Patients with unstable clinical condition that in the opinion of the PI precludes participation in the study. Inability to tolerate 60 minutes in a supine position with arms down at sides. Contraindications to MR imaging, (pacemaker, brain aneurysm clips, shrapnel, etc. Positive pregnancy test or lactating. Have another conditions such as cancer or autoimmune/inflammatory diseases, e.g. rheumatoid arthritis or multiple sclerosis that are known to have increased expression of CCR2. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kitty Harrison, BSN, RN
Phone
314-747-0183
Email
harrisonk@mir.wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Gropler, M.D.
Phone
314-747-0183
Email
groplerr@mir.wustl.edu
Facility Information:
Facility Name
Washington University CCIR
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Mohrman

12. IPD Sharing Statement

Learn more about this trial

PET Detection of CCR2 in Human Atherosclerosis

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