Rubidium Elution System Performance Testing

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02117284
• Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief Summary

Rubidium is a newly approved nuclear medicine imaging drug or 'tracer' used to look at blood flow in the heart. This tracer is given using a special pump called an 'elution system' which is considered investigational. This means the device is not yet approved by Health Canada for general use, but it has been approved for use in this study. It has been used routinely in this hospital since 2010.

The purpose of this study is to confirm proper operation of the pump. It may also help identify areas for future improvement. The study data may be used for safety reporting to the Ministry of Health or to Health Canada. The study will enroll 2,400 patients in 6 hospitals across Canada. The University of Ottawa Heart Institute (UOHI) will enroll up to 1,200 patients.

Detailed Description

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:

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

1. elution activity (82Rb) bias \< 5% (V2 and V3)

2. elution activity (82Rb) imprecision \< 5% (V2 and V3)

3. elution time interval (30 s) bias \< 5% (V2 only)

4. elution success-rate reliability \> 98% (failure-rate \< 2%) (V2 and V3)

2. Daily Quality Assurance: testing procedures are adequate to document:

1. Automated generator yield (82Rb) imprecision \< 10% (V2 only)

2. Automated generator breakthrough (82Sr, 85Sr) imprecision \< 10% (V2 and V3)

3. Manual generator yield (82Rb) imprecision \< 10% (V2 only)

4. Manual generator breakthrough (82Sr, 85Sr) imprecision \< 10% (V2 only)

3. Monthly Quality Assurance: testing procedures are adequate to document:

1. Dose calibrator non-linearity \< 1% (V2 and V3)

2. Dose calibrator constancy \> 99% (instability \< 1%) (V2 only)

3. Dose calibrator bias \< 10% (V2 only)

4. Peristaltic pump calibration bias \< 10% (V2 only) 2.2 Secondary Objectives: To evaluate the user documentation and training reliability for:

4. Installation of the Ruby-Fill generator and Ruby-Set tubing (V2 and V3)

5. 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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-17
• Status Verified: 2018-05
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15800

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
System Performance:	1 year	System operation using constant-activity infusion is adequate to achieve: 1. elution activity (82Rb) bias \< 5% (V2 and V3); 2. elution activity (82Rb) imprecision \< 5% (V2 and V3); 3. elution time interval (30 s) bias \< 5% (V2 only); 4. elution success-rate reliability \> 98% (failure-rate \< 2%) (V2 and V3)
Daily Quality Assurance:	1 year	System testing procedures are adequate to document: 1. Automated generator yield (82Rb) imprecision \< 10% (V2 only); 2. Automated generator breakthrough (82Sr, 85Sr) imprecision \< 10% (V2 and V3); 3. Manual generator yield (82Rb) imprecision \< 10% (V2 only); 4. Manual generator breakthrough (82Sr, 85Sr) imprecision \< 10% (V2 only)
Monthly Quality Assurance	1 year	System testing procedures are adequate to document: 1. Dose calibrator non-linearity \< 1% (V2 and V3); 2. Dose calibrator constancy \> 99% (instability \< 1%) (V2 only); 3. Dose calibrator bias \< 10% (V2 only); 4. Peristaltic pump calibration bias \< 10% (V2 only)

Secondary Outcome Measures

Name	Time	Method
User documentation	1 year	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)

Trial Locations

Locations (4)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Hamilton Healath Sciences Centre; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada