Myocardial Perfusion Imaging Galmydar Rest/Stress

NCT05625490 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: 202107042-2R01HL142297
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Myocardial Perfusion imaging; Pharmacological Stress; Positron Emission Tomography; Myocardial Blood Flow

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (17)

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

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

• Change in systolic or diastolic blood pressure.

  6 hours from 68Ga-Galmydar injection

• Change in heart rate.

  6 hours from 68Ga-Galmydar injection

• Clinically significant change in respiratory rate.

  6 hours from 68Ga-Galmydar injection

• Clinically significant elevation in oral temperature

  6 hours from 68Ga-Galmydar injection

Study Arms (3)

Asymptomatic Subjects (Normal Controls)

EXPERIMENTAL

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.

Drug: Ga-68 Galmydar; Drug: 13N-ammonia

Symptomatic Patients with Normal Clinical SPECT or PET

EXPERIMENTAL

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.

Drug: Ga-68 Galmydar

Symptomatic Patients with Abnormal Clinical SPECT or PET

EXPERIMENTAL

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.

Drug: Ga-68 Galmydar

Interventions

Ga-68 Galmydar DRUG

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

Also known as: IND 157468

Asymptomatic Subjects (Normal Controls); Symptomatic Patients with Abnormal Clinical SPECT or PET; Symptomatic Patients with Normal Clinical SPECT or PET

13N-ammonia DRUG

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

Asymptomatic Subjects (Normal Controls)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 29454148 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Pamela K Woodard, M.D

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elizabeth E Mallinckrodt Professor of Radiology

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 23, 2022
• Study Start: November 11, 2022
• Primary Completion: December 17, 2025
• Study Completion: December 19, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)