Myocardial Perfusion Imaging Galmydar Rest/Stress

Early Phase 1CompletedNCT05625490

Washington University School of Medicine15 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Ga-68 GalmydarDRUG

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

13N-ammoniaDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Change in systolic or diastolic blood pressure.

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