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NCT05625490CompletedEarly phase 1

Myocardial Perfusion Imaging Galmydar Rest/Stress

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

Source: ClinicalTrials.gov · Last updated 7 Jan 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
15 (actual)
First submitted
13 Nov 2022
Start date
11 Nov 2022
Primary completion date
17 Dec 2025
Lead sponsor
Washington University School of Medicine
NCT number
NCT05625490

What you commit to

  • Study type: Interventional · Early phase 1
  • Participants enrolled: 15
  • From 11 Nov 2022 to the primary completion date, 17 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • 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;

Other illness

  • 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);
  • 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;

Lab values

  • Heart failure (left ventricular ejection fraction ≤ 20%);

Other

  • Inability to receive and sign informed consent;
  • Known non-ischemic cardiomyopathy;
  • Women who are pregnant or breastfeeding;
  • Severe claustrophobia;
  • Weight ≥ 500 lbs (weight limit of PET/CT table);

Who the study is looking for

  • 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;

Age in the registry: 18 years to 99 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.