Myocardial Perfusion Imaging Galmydar Rest/Stress

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 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.

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

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

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.

On Imaging Day-2, participants will receive two single administrations each of 10 mCi of 13N-Ammonia during the rest and stress PET MPI.

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

Assessment of regional (17segment) myocardial blood flow (MBF) at stress and rest perfusion on 68Ga-Galmydar PET/CT.

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.

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.

Serum chemistries (total protein, albumin), measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

Serum chemistries (alkaline phosphatase), measured in U/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

White blood cell count measured in WBC/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

Hgb measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

Hct measured in %. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

Platelets measured in platelets/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

RBC measured in million/mm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

MCV measured in µm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

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)

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.