Myocardial Perfusion Imaging Galmydar Rest/Stress

NCT ID: NCT05625490

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2025-12-19

Brief Summary

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

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Asymptomatic Subjects (Normal Controls)

Normal 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.

Group Type: EXPERIMENTAL

Ga-68 Galmydar

Intervention Type: DRUG

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

13N-ammonia

Intervention Type: DRUG

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

Symptomatic Patients with Normal Clinical SPECT or PET

Patients 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.

Group Type: EXPERIMENTAL

Ga-68 Galmydar

Intervention Type: DRUG

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

Symptomatic Patients with Abnormal Clinical SPECT or PET

Patients 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.

Group Type: EXPERIMENTAL

Ga-68 Galmydar

Intervention Type: DRUG

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

Interventions

Ga-68 Galmydar

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

Intervention Type: DRUG

13N-ammonia

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

Intervention Type: DRUG

Other Intervention Names

IND 157468

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Pamela Woodard, MD

Elizabeth E Mallinckrodt Professor of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela K Woodard, M.D

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29454148 (View on PubMed)

Other Identifiers

R01HL142297

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202107042-2

Identifier Type: -

Identifier Source: org_study_id