Myocardial Perfusion Imaging Galmydar Rest/Stress

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625490
• Other study ID #: 202107042-2
• Secondary ID: R01HL142297
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 11, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Dakkota M Thies
• Phone: 314-747-3839
• Email: d.thies[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• Ga-68 Galmydar
Two intravenous injection of the PET radiotracer 68Ga-Galmydar.
• 13N-ammonia
Two intravenous Injection of PET radiotracer 13N-Ammonia.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in heart rate.	A 20 BPM change in heart rate from baseline.	6 hours from 68Ga-Galmydar injection
Secondary	Clinically significant change in respiratory rate.	A respiratory rate of < 12 or > 20 breaths/min.	6 hours from 68Ga-Galmydar injection
Secondary	Clinically significant elevation in oral temperature	Oral temperature of >100 degrees F.	6 hours from 68Ga-Galmydar injection
Secondary	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
Secondary	Number of patients with new bradycardia	New heart rate < 40 BPM on EKG.	6 hours from 68Ga-Galmydar injection
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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