Rubidium Elution System Performance Testing

NCT02117284 | Completed

• 1 other identifier: 20130344
• Study Type: observational
• Target: 15,800
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronary Artery Disease

Keywords

positron emission tomography (PET); Rubidium-82; myocardial perfusion imaging; automated elution system; controlled radioactivity delivery

Outcome Measures

Primary Outcomes (3)

• 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)

  1 year

• 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)

  1 year

• 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)

  1 year

Secondary Outcomes (1)

• User documentation

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Jubilant DraxImage Inc.: collaborator

Study Sites (4)

Hamilton Healath Sciences Centre

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 17228112 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Rob S Beanlands, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Cardiology

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 17, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-05

Locations

CA (4)