Myocardial Perfusion Imaging Galmydar Rest/Stress

Study Overview
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Brief Summary
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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
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The primary objective of the proposed study is to evaluate the potential of [68Ga]Galmydar PET/CT MPI for the noninvasive detection of coronary artery disease. The study will evaluate [68Ga]Galmydar PET/CT MPI in comparison to [13N]ammonia 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 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 SPECT 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. The primary objective of the proposed study is to evaluate the potential of [68Ga]Galmydar PET/CT MPI for the noninvasive detection of coronary artery disease. The study will evaluate [68Ga]Galmydar PET/CT MPI in comparison to [13N]ammonia PET/CT MPI in the same subjects 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 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 SPECT 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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Ga-68 Galmydar
* Drug: 13N-ammonia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female, 18-99 years of age and any race; Have had a prior clinical SPECT MPI positive for ischemia in two myocardial segments and referred for invasive coronary angiography (ICA) or have had a prior clinical SPECT MPI negative for ischemia; Exclusion Criteria: Inability to receive and sign informed consent; Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6-months prior to SPECT or in the intervening days between SPECT and PET examination; Participants who have received chemotherapeutic agents within 6 months of enrollment; Heart failure (left ventricular ejection fraction ≤ 35%); 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with known or suspected disease and normal controls (no known disease) will both undergo [68Ga]Galmydar PET/CT MPI and [13N]ammonia PET/CT MPI
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rest/ Stress imaging day 1<br>Participants will receive two [68Ga]Galmydar intravenous administrations, 4 mCi during rest and 8 mCi during stress for the PET MPI performed on Imaging Day-1. | Drug: Ga-68 Galmydar<br>* Two intravenous injection of the PET radiotracer 68Ga-Galmydar.<br>* Other names: IND 157468;|
| Experimental: rest/ stress imaging day 2<br>On Imaging Day-2, participants will receive two single administrations each of 10 mCi of 13N-Ammonia during the rest and stress PET MPI. | Drug: 13N-ammonia<br>* Two intravenous Injection of PET radiotracer 13N-Ammonia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Comparison to regional uptake on 13N-ammonia PET/CT performed 3-30 days after the 68Ga-Galmydar PET/CT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Comparison to regional MBF on 13N-ammonia PET/CT performed 3-30 days after the 68Ga-Galmydar PET/CT | 
| Change in systolic or diastolic blood pressure. | A 20 mmHg change from baseline in either systolic or diastolic blood pressure. | 6 hours from 68Ga-Galmydar injection | 
| Change in heart rate. | A 20 BPM change in heart rate from baseline. | 6 hours from 68Ga-Galmydar injection | 
| Clinically significant change in respiratory rate. | A respiratory rate of < 12 or > 20 breaths/min. | 6 hours from 68Ga-Galmydar injection | 
| Clinically significant elevation in oral temperature | Oral temperature of >100 degrees F. | 6 hours from 68Ga-Galmydar injection | 
| 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). | 6 hours from 68Ga-Galmydar injection | 
| Number of patients with new bradycardia | New heart rate < 40 BPM on EKG. | 6 hours from 68Ga-Galmydar injection | 
| 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. | 6 hours from 68Ga-Galmydar injection | 
| 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. | 6 hours from 68Ga-Galmydar injection | 
| 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. | 6 hours from 68Ga-Galmydar injection | 
| Clinically significant change in serum chemistries: alkaline phosphatase, ALT, AST | Serum chemistries (alkaline phosphatase), measured in U/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 
| 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. | 6 hours from 68Ga-Galmydar injection | 
| 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. | 6 hours from 68Ga-Galmydar injection | 
| Clinically significant change in hematocrit (Hct) | Hct measured in %. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 
| 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. | 6 hours from 68Ga-Galmydar injection | 
| 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. | 6 hours from 68Ga-Galmydar injection | 
| 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. | 6 hours from 68Ga-Galmydar injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Perfusion imaging, Pharmacological Stress, Positron Emission Tomography, Myocardial Blood Flow