Purpose

To determine the feasibility of 64Cu-DOTA-ECL1i, an investigational PET imaging drug, at the cellular level in the myocardium for individuals who have suffered a heart attack or who have other inflammatory heart disease.

Condition

Eligibility

Eligible Ages
Between 21 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Healthy Volunteers: 2. Age 21 to 80 years of either sex, any race 3. Capable of lying still and supine within the PET/CT and PET/MR scanner for 1 hour and follow instructions for breathing protocol during the CT portion 4. No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year 5. No known history of cardiac. pulmonary, hepatic, or renal disease or diabetes 6. No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions 7. Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol. Inflammatory Heart Disease 1. Age 21 to 80 years of either sex, any race who have suffered a STEMI within the past 6 months as well as other forms of inflammatory heart disease including sarcoidosis, myocarditis, cardiomyopathy, injected cardiovascular implantable electronic devices pacemakers/LVAD 2. Are clinically stable to undergo imaging with either PET/MR or PET/CT. 3. Capacity to give written informed consent and ability to follow study procedures 4. Pre-menopausal women must have a negative urine pregnancy test within 24 hours prior to the administration of 64-Cu-DOTA-ECL1i.

Exclusion Criteria

Healthy volunteers: 1. Currently enrolled in another study using an investigational drug 2. Angina 3. Uncontrolled heart failure 4. uncontrolled hypertension baseline hypotension below 90/50 5. Has any condition that in the opinion of the PI or designee that could increase risk to the subject 6. Is deemed likely to be unable to perform all research procedures 7. Have contraindications to PET/CT imaging like claustrophobia 8. Have contraindication to gadolinium 9. Pregnant or breastfeeding 10. Currently using recreational drubs 11. Body weight of more than 300 lbs 12. Active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes 13. currently taking any prescription medications 14. Presence of an implanted device incompatible with CT or MRI scanning Inflammatory Heart Disease 1) Clinically unstable including post MI angina, uncontrolled heart failure, sever hypertension, hypotension AV block 2) Has any condition that in the opinion of the PI could increase risk to the subject 3) Claustrophobia 4) contraindication to gadolinium contrast 5) Pregnant 6) Currently using recreational drugs 7) Body Weight more than 300 lbs 8) Currently enrolled in another study

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Post ST Elevation Myocardial Infarction/ Heart Attack
Image patients who have had a heart attack
  • Drug: 64Cu-DOTA-ECL1i
    Inject PET Radioisotope for imaging
    Other names:
    • Imaging drug
Active Comparator
Sarcoidosis
Image patients who have Sarcoidosis
  • Drug: 64Cu-DOTA-ECL1i
    Inject PET Radioisotope for imaging
    Other names:
    • Imaging drug
Active Comparator
Myocarditis
Image patients with Myocarditis
  • Drug: 64Cu-DOTA-ECL1i
    Inject PET Radioisotope for imaging
    Other names:
    • Imaging drug
Active Comparator
Cardiomyopathy
Image patients with cardiomyopathy
  • Drug: 64Cu-DOTA-ECL1i
    Inject PET Radioisotope for imaging
    Other names:
    • Imaging drug
Active Comparator
Infected Cardiovascular Implantable Electronic Devices
Image patients with cardiovascular implanted medical devices
  • Drug: 64Cu-DOTA-ECL1i
    Inject PET Radioisotope for imaging
    Other names:
    • Imaging drug
Active Comparator
Healthy Volunteers
Image healthy volunteers
  • Drug: 64Cu-DOTA-ECL1i
    Inject PET Radioisotope for imaging
    Other names:
    • Imaging drug

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Kitty Harrison
314-747-0183
harrisonk@mir.wustl.edu

More Details

NCT ID
NCT05107596
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Kitty D Harrison, BSN, RN
314-747-0183
kittydharrison@wustl.edu

Detailed Description

To determine the feasibility of 64Cu-DOTA-ECL1i to detect CCR2+monocytes and macrophages which are cells that are responsible for protecting tissues from foreign substances in the myocardium by PET/MR and PET/CT.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.