New heart scan tracer could make diagnosis easier
NCT ID NCT05625490
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tested a new radioactive tracer called Ga-68 Galmydar for PET scans of the heart. The goal was to see if it can accurately show blood flow to the heart muscle in people with or without coronary artery disease. Fifteen adults received the tracer and underwent imaging, with results compared to a standard tracer. The study aims to develop a more convenient option for heart imaging.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ga-68 Galmydar (a radioactive tracer for PET scans)
- What this could lead to
- If successful, this could lead to a more accessible PET tracer for diagnosing coronary artery disease, potentially replacing tracers that require a nearby cyclotron.
- What could go wrong
- This is a very early, small study (15 participants) focused on imaging feasibility, not treatment. The tracer may not prove superior to existing methods or may have safety issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
15 people
The number who actually took part.
- Started
-
Nov 2022
- Finished
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Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 99 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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