Myocardial Perfusion Imaging Galmydar Rest/Stress

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)

Criteria

Inclusion 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;

Exclusion Criteria:

• 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)