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Coronary Artery DiseaseEarly Phase 1NCT05625490

Myocardial Perfusion Imaging Galmydar Rest/Stress

A Early Phase 1 study testing Ga-68 Galmydar and 13N-ammonia in people with Coronary Artery Disease, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Coronary Artery Disease
What is being tested?
Ga-68 Galmydar and 13N-ammonia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
11 Nov 2022to 19 Dec 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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:
Show all 18Show fewer
  • 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;

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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

Read the detailed description

The primary objective of the proposed study is to evaluate the potential of [68Ga]Galmydar PET/CT myocardial perfusion imaging (MPI) for the noninvasive detection of coronary artery disease. The study will evaluate [68Ga]Galmydar PET/CT MPI to semi-quantitatively assess regional myocardial perfusion and quantitatively assess myocardial blood flow (MBF) in patients with suspected or known coronary artery disease (CAD) undergoing clinical SPECT or PET MPI. In addition, perfusion and MBF findings with [68Ga]Galmydar will be compared to the results of coronary morphology or stenosis severity in those patients undergoing invasive coronary angiography (ICA) based on abnormal clinical SPECT or PET MPI. The performance of rest/stress [68Ga]Galmydar PET/CT in comparison to [13N]ammonia PET/CT in normal subjects without cardiovascular disease will be performed as a control. Vital signs, serum chemistries, and serum blood counts will also be obtained.

Being tested
Ga-68 Galmydar, 13N-ammonia
Keywords
Myocardial Perfusion imaging, Pharmacological Stress, Positron Emission Tomography, Myocardial Blood Flow
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ga-68 GalmydarDrug

    Also called IND 157468

    Intravenous injections of the PET radiotracer [68Ga]Galmydar.

  • 13N-ammoniaDrug

    Two intravenous injections of PET radiotracer [13N]Ammonia.

Study groups in NCT05625490
Study groupRoleWhat they receive
Asymptomatic Subjects (Normal Controls)ExperimentalNormal control subjects are asymptomatic, without history of cardiovascular disease or significant cardiovascular risk factors. These participants will receive two [68Ga]Galmydar intravenous administrations, 2 mCi during rest and 4 mCi during stress for the [68Ga]Galmydar PET MPI performed on Imaging Day-1. On Imaging Day-2, asymptomatic subjects will receive two single intravenous administrations each of 10 mCi of [13N]Ammonia during the rest and stress PET MPI. [68Ga]Galmydar and [13N]Ammonia imaging visits will be separated by a minimum of 3 days.
Receives: Drug: Ga-68 Galmydar; Drug: 13N-ammonia
Symptomatic Patients with Normal Clinical SPECT or PETExperimentalPatients in this group have had a clinical SPECT or PET MPI examination that is normal and do not have an invasive coronary angiography (ICA) referral. Participants will receive one [68Ga]Galmydar intravenous administration, 2 mCi during rest for the [68Ga]Galmydar PET MPI.
Receives: Drug: Ga-68 Galmydar
Symptomatic Patients with Abnormal Clinical SPECT or PETExperimentalPatients in this group have had a clinical SPECT or PET MPI examination that is positive for ischemia in two myocardial segments and have been referred for invasive coronary angiography (ICA) as part of their routine standard-of-care. Subjects will undergo [68Ga]Galmydar PET/CT prior to any intervention. Participants will receive one [68Ga]Galmydar intravenous administration, 2 mCi during rest.
Receives: Drug: Ga-68 Galmydar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Semiquantitative assessment of 68Ga-Galmydar PET/CT uptake

    Assessment of regional (17segment) myocardial uptake on 5-point scale (0 = normal; 4 = absent tracer uptake) per independent blind readout by 3 expert cardiac PET physicians.

    Measured: Up to 120 minutes post-injection of 68Ga-Galmydar

Secondary outcomes (17)

  1. Assessment of myocardial blood flow on 68Ga-Galmydar PET/CT

    Assessment of regional (17segment) myocardial blood flow (MBF) at stress and rest perfusion on 68Ga-Galmydar PET/CT.

    Measured: Up to 120 minutes post-injection of 68Ga-Galmydar

  2. Change in systolic or diastolic blood pressure.

    A 20 mmHg change from baseline in either systolic or diastolic blood pressure.

    Measured: 6 hours from 68Ga-Galmydar injection

  3. Change in heart rate.

    A 20 BPM change in heart rate from baseline.

    Measured: 6 hours from 68Ga-Galmydar injection

  4. Clinically significant change in respiratory rate.

    A respiratory rate of < 12 or > 20 breaths/min.

    Measured: 6 hours from 68Ga-Galmydar injection

  5. Clinically significant elevation in oral temperature

    Oral temperature of >100 degrees F.

    Measured: 6 hours from 68Ga-Galmydar injection

  6. Number of patients with new AV Block

    A change in EKG showing new AV Block (Type 1 or Type 2), Mobitz 2:1, or QTc ≥ 500ms.

    Measured: 6 hours from 68Ga-Galmydar injection

  7. Number of patients with new bradycardia

    New heart rate < 40 BPM on EKG.

    Measured: 6 hours from 68Ga-Galmydar injection

  8. Clinically significant change in serum chemistries: sodium, potassium, chloride, CO2

    Serum chemistries (sodium, potassium, chloride, CO2) measured in mmol/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  9. Clinically significant change in serum chemistries: glucose, calcium creatinine, BUN, total bilirubin

    Serum chemistries (glucose, calcium creatinine, BUN, total bilirubin), measured in mg/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  10. Clinically significant change in serum chemistries: total protein, albumin.

    Serum chemistries (total protein, albumin), measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  11. Clinically significant change in serum chemistries: alkaline phosphatase, ALT, AST

    Serum chemistries (alkaline phosphatase, ALT, AST), measured in U/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  12. Clinically significant change in white blood cell count (WBC)

    White blood cell count measured in WBC/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  13. Clinically significant change in hemoglobin (Hgb)

    Hgb measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  14. Clinically significant change in hematocrit (Hct)

    Hct measured in %. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  15. Clinically significant change in platelets

    Platelets measured in platelets/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  16. Clinically significant change in red blood cell count (RBC)

    RBC measured in million/mm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  17. Clinically significant change in mean corpuscular volume (MCV)

    MCV measured in µm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2022
  2. Study start11 Nov 2022
  3. Primary completion17 Dec 2025
  4. Study completion19 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients with known or suspected disease and normal controls (no known disease) will both undergo \[68Ga\]Galmydar PET/CT MPI. Normal controls will also undergo \[13N\]ammonia PET/CT MPI.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05625490
Sponsor's protocol ID
202107042-2
Other IDs
R01HL142297
Status last verified
Jan 2026
First submitted
13 Nov 2022
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sivapackiam J, Laforest R, Sharma V. 68Ga[Ga]-Galmydar: Biodistribution and radiation dosimetry studies in rodents. Nucl Med Biol. 2018 Apr;59:29-35. doi: 10.1016/j.nucmedbio.2017.11.008. Epub 2017 Dec 1.

    PubMed 29454148

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ga-68 Galmydar and 13N-ammonia in people with Coronary Artery Disease, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Semiquantitative assessment of 68Ga-Galmydar PET/CT uptake (time frame: Up to 120 minutes post-injection of 68Ga-Galmydar). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05625490, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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