Myocardial Perfusion Imaging Galmydar Rest/Stress

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

This study is testing a new imaging method to see how well the heart is getting blood during rest and stress in people with heart conditions.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Washington University School of Medicine (Academic / other)
• Locations: 1 site (Saint Louis, Missouri)
• Trial ID: NCT05625490 on ClinicalTrials.gov

What this trial studies

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Who should consider this trial

Good fit: Unknown

Not a fit: Unknown

Why it matters

Potential benefit: Unknown

How similar studies have performed: Unknown

Eligibility criteria

Inclusion Criteria:

* Male and female, 18-99 years of age and any race;
* Have had a prior clinical SPECT or PET MPI positive for ischemia in two myocardial segments and referred for invasive coronary angiography (ICA) or have had a prior clinical SPECT or PET MPI negative for ischemia or healthy adult normal volunteers who are asymptomatic, without history of cardiovascular disease or significant cardiovascular risk factors;

Exclusion Criteria:

* Inability to receive and sign informed consent;
* Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6-months prior to clinical SPECT or PET or in the intervening days between clinical SPECT or PET and research PET examination;
* Participants who have received chemotherapeutic agents within 6 months of enrollment;
* Heart failure (left ventricular ejection fraction ≤ 20%);
* 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;

Where this trial is running

Saint Louis, Missouri

• Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)

Study contacts

• Principal investigator: Pamela K Woodard, M.D — Washington University School of Medicine
• Study coordinator: Dakkota M Thies

Conditions Coronary Artery Disease; Myocardial Perfusion imaging; Pharmacological Stress; Positron Emission Tomography; Myocardial Blood Flow