Rubidium Elution System Performance Testing

Primary Objectives: To evaluate performance of the rubidium elution systems (RBES) manufactured by Jubilant DraxImage (JDI); specifically using the constant-activity-rate intravenous infusion of rubidium-82 from the Ruby-Fill™ generator for diagnostic imaging of myocardial perfusion with PET. The V3 elution system is more highly automated, therefore requiring fewer manual performance checks.

Hypotheses:

• Performance: system operation using constant-activity infusion is adequate to achieve:

• elution activity (82Rb) bias < 5% (V2 and V3)
• elution activity (82Rb) imprecision < 5% (V2 and V3)
• elution time interval (30 s) bias < 5% (V2 only)
• elution success-rate reliability > 98% (failure-rate < 2%) (V2 and V3)
• Daily Quality Assurance: testing procedures are adequate to document:

• Automated generator yield (82Rb) imprecision < 10% (V2 only)
• Automated generator breakthrough (82Sr, 85Sr) imprecision < 10% (V2 and V3)
• Manual generator yield (82Rb) imprecision < 10% (V2 only)
• Manual generator breakthrough (82Sr, 85Sr) imprecision < 10% (V2 only)
• Monthly Quality Assurance: testing procedures are adequate to document:

• Dose calibrator non-linearity < 1% (V2 and V3)
• Dose calibrator constancy > 99% (instability < 1%) (V2 only)
• Dose calibrator bias < 10% (V2 only)
• Peristaltic pump calibration bias < 10% (V2 only) 2.2 Secondary Objectives: To evaluate the user documentation and training reliability for:
• Installation of the Ruby-Fill generator and Ruby-Set tubing (V2 and V3)
• Trouble-shooting and repair of system errors (e.g. high-pressure) (V2 and V3) 2.3 Tertiary Objective: To evaluate patient demographics or health status effects on system performance

Inclusion criteria

All patients presenting to participating nuclear imaging facilities with Rb-82 PET for diagnosis and/or risk stratification for CAD (as listed in the approved Ruby-Fill product monograph), who are at least 18 years of age and have given informed consent or those who have consented to and are currently participating in an Ottawa Health Science Network Research Ethics Board (OHSN-REB) approved protocol utilizing Rb-82 PET will be eligible.

Exclusion criteria

• Patients with contraindications to stress radionuclide imaging including:
• Severe reactive airway disease;
• <3 days post myocardial infarction (MI) or acute coronary syndrome (ACS) presentation;
• Unstable crescendo angina;
• High grade atrioventricular (AV) block;
• Severe claustrophobia;
• Patients who are or may be pregnant will be excluded.