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Rubidium Elution System Performance Testing (REST-PET)

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ClinicalTrials.gov Identifier: NCT02117284
Recruitment Status : Recruiting
First Posted : April 17, 2014
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Jubilant DraxImage Inc.
Information provided by (Responsible Party):
Rob Beanlands, 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.


Condition or disease
Coronary Artery Disease

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 Type : Observational [Patient Registry]
Estimated Enrollment : 7500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Rubidium Elution System Performance Testing
Study Start Date : January 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rubidium

Group/Cohort
Coronary artery disease
All patients present to participating nuclear imaging facilities for diagnosis of CAD and/or risk stratification with Rubidium PET. Subjects will be enrolled according to the clinical indications listed in the approved Ruby-Fill product monograph.



Primary Outcome Measures :
  1. System Performance: [ Time Frame: 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)

  2. Daily Quality Assurance: [ Time Frame: 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)

  3. Monthly Quality Assurance [ Time Frame: 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 :
  1. User documentation [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients present to participating nuclear imaging facilities for diagnosis of CAD and/or risk stratification with Rubidium PET. Subjects will be enrolled according to the clinical indications listed in the approved Ruby-Fill product monograph.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117284


Contacts
Contact: Linda M Garrard, BScN 613-696-7000 ext 14192 lgarrard@ottawaheart.ca
Contact: Robert A deKemp, PhD 613-696-7374 radekemp@ottawaheart.ca

Locations
Canada, Ontario
Hamilton Healath Sciences Centre Recruiting
Hamilton, Ontario, Canada
Contact: Karen Gulenchyn, MD       gulenkar@HHSC.CA   
Principal Investigator: Karen Gulenchyn, MD         
Sub-Investigator: Christopher Marriott, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Anna MacDonald, RN         
Principal Investigator: Gerald Wisenberg, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Linda M Garrard, BScN    613-696-7000 ext 14192    lgarrard@ottawaheart.ca   
Contact: Robert A deKemp, PhD    613-696-7374    radekemp@ottawaheart.ca   
Principal Investigator: Robert A deKemp, PhD         
University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Robert M Iwanochko, MD       robertmark.iwanochko@uhn.on.ca   
Principal Investigator: Robert M Iwanochko, MD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Jubilant DraxImage Inc.
Investigators
Principal Investigator: Rob S Beanlands, MD Ottawa Heart Institute Research Corporation

Publications:
Responsible Party: Rob Beanlands, Chief, Division of Cardiology, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02117284     History of Changes
Other Study ID Numbers: 20130344
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Keywords provided by Rob Beanlands, Ottawa Heart Institute Research Corporation:
positron emission tomography (PET)
Rubidium-82
myocardial perfusion imaging
automated elution system
controlled radioactivity delivery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases