Clinical trial NCT05625490: Myocardial Perfusion Imaging Galmydar Rest/Stress
Official title: Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Coronary Artery Disease
Keywords: Myocardial Perfusion imaging
Pharmacological Stress
Positron Emission Tomography
Myocardial Blood Flow
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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;

Primary outcomes:
measure: Semiquantitative assessment of 68Ga-Galmydar PET/CT uptake
timeFrame: Up to 120 minutes post-injection of 68Ga-Galmydar
Secondary outcomes:
measure: Assessment of myocardial blood flow on 68Ga-Galmydar PET/CT
timeFrame: Up to 120 minutes post-injection of 68Ga-Galmydar
measure: Change in systolic or diastolic blood pressure.
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Change in heart rate.
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant change in respiratory rate.
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant elevation in oral temperature
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Number of patients with new AV Block
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Number of patients with new bradycardia
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant change in serum chemistries: sodium, potassium, chloride, CO2
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant change in serum chemistries: glucose, calcium creatinine, BUN, total bilirubin
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant change in serum chemistries: total protein, albumin.
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant change in serum chemistries: alkaline phosphatase, ALT, AST
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant change in white blood cell count (WBC)
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant change in hemoglobin (Hgb)
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant change in hematocrit (Hct)
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant change in platelets
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant change in red blood cell count (RBC)
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically significant change in mean corpuscular volume (MCV)
timeFrame: 6 hours from 68Ga-Galmydar injection
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Pamela K Woodard, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.