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Coronary Artery DiseaseREST-PETNCT02117284

Rubidium Elution System Performance Testing

An observational study of Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
How many people
15,800 participants
Where
4 sitesCanada
Study dates
Jan 2014to Sep 2018
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Hamilton Healath Sciences Centre

    Hamilton, Ontario

  • London Health Sciences Centre

    London, Ontario

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • University Health Network

    Toronto, Ontario

Other trials in Canada

About this study

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.

Read the 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:
  2. elution activity (82Rb) bias < 5% (V2 and V3)
  3. elution activity (82Rb) imprecision < 5% (V2 and V3)
  4. elution time interval (30 s) bias < 5% (V2 only)
  5. elution success-rate reliability > 98% (failure-rate < 2%) (V2 and V3)
  6. Daily Quality Assurance: testing procedures are adequate to document:
  7. Automated generator yield (82Rb) imprecision < 10% (V2 only)
  8. Automated generator breakthrough (82Sr, 85Sr) imprecision < 10% (V2 and V3)
  9. Manual generator yield (82Rb) imprecision < 10% (V2 only)
  10. Manual generator breakthrough (82Sr, 85Sr) imprecision < 10% (V2 only)
  11. Monthly Quality Assurance: testing procedures are adequate to document:
  12. Dose calibrator non-linearity < 1% (V2 and V3)
  13. Dose calibrator constancy > 99% (instability < 1%) (V2 only)
  14. Dose calibrator bias < 10% (V2 only)
  15. Peristaltic pump calibration bias < 10% (V2 only) 2.2 Secondary Objectives: To evaluate the user documentation and training reliability for:
  16. Installation of the Ruby-Fill generator and Ruby-Set tubing (V2 and V3)
  17. 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
Keywords
positron emission tomography (PET), Rubidium-82, myocardial perfusion imaging, automated elution system, controlled radioactivity delivery
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02117284
Study groupRoleWhat they receive
Coronary artery diseaseAll 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. System 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)

    Measured: 1 year

  2. Daily Quality Assurance:

    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)

    Measured: 1 year

  3. Monthly Quality Assurance

    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)

    Measured: 1 year

Secondary outcomes (1)

  1. User documentation

    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)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionSep 2018
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15,800 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT02117284
Sponsor's protocol ID
20130344
Acronym
REST-PET
Status last verified
May 2018
First submitted
15 Apr 2014
Last updated
24 Dec 2018
Results posted
No
Data monitoring committee
No

Publications

  • Klein R, Adler A, Beanlands RS, Dekemp RA. Precision-controlled elution of a 82Sr/82Rb generator for cardiac perfusion imaging with positron emission tomography. Phys Med Biol. 2007 Feb 7;52(3):659-73. doi: 10.1088/0031-9155/52/3/009. Epub 2007 Jan 11.

    PubMed 17228112

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

System Performance: (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02117284, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.

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Rubidium Elution System Performance Testing | AzTrials