Myocardial Perfusion Imaging Galmydar Rest/Stress

Description

A single center, phase 0/1 clinical imaging study designed to assess the role of \[68Ga\]Galmydar PET/CT imaging in human subjects.

Conditions

Coronary Artery Disease

Study Overview

Study Details

Study overview

A single center, phase 0/1 clinical imaging study designed to assess the role of \[68Ga\]Galmydar PET/CT imaging in human subjects.

Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging

Myocardial Perfusion Imaging Galmydar Rest/Stress

Condition
Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male and female, 18-99 years of age and any race;
  • * Have had a prior clinical SPECT MPI positive for ischemia in two myocardial segments and referred for invasive coronary angiography (ICA) or have had a prior clinical SPECT MPI negative for ischemia or healthy adult normal volunteers who are asymptomatic, without history of cardiovascular disease or significant cardiovascular risk factors;
  • * Inability to receive and sign informed consent;
  • * Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6-months prior to SPECT or in the intervening days between SPECT and PET examination;
  • * Participants who have received chemotherapeutic agents within 6 months of enrollment;
  • * Heart failure (left ventricular ejection fraction ≤ 35%);
  • * Known non-ischemic cardiomyopathy;
  • * Inability to undergo pharmacologic stress testing with regadenoson (Lexiscan). Contraindications include:
  • * Symptomatic bradycardia or second to third degree atrioventricular (AV) block;
  • * Pre-existing obstructive lung disease with active wheezing, i.e., COPD, asthma with active wheezing that precludes the safe administration of the pharmacological stress agent according to the approved label;
  • * Uncontrolled and severe hypertension (e.g. systolic blood pressure \>200 mmHg, diastolic blood pressure \>110 mmHg);
  • * Baseline hypotension (e.g. systolic blood pressure \< 90 mmHg, diastolic blood pressure \<50 mmHg);
  • * Women who are pregnant or breastfeeding;
  • * Severe claustrophobia;
  • * Weight ≥ 500 lbs (weight limit of PET/CT table);
  • * Administration of any diagnostic or therapeutic radiopharmaceutical, not part of this study, within a period either prior to or after equal to 10 half-lives of the radiopharmaceutical;
  • * Any condition that in the opinion of the Principal 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:
  • * Inability to lie still or unable to tolerate a supine position with arms up over the head for up to a 60-minute PET scan due to chronic back/shoulder pain or arthritis as assessed by physical examination and/or medical history;
  • * Current or past history of major medical illness, i.e. severe kidney or liver problems;
  • * Patients who suffer an intervening clinical event such as worsening angina pectoris or myocardial infarction or whom undergo a myocardial revascularization procedure or have myocardial ischemia at rest;

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Washington University School of Medicine,

Pamela K Woodard, M.D, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

2025-04-01