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Rubidium-82 - An Alternative Radiopharmaceutical for Myocardial Imaging(Rb-ARMI)

NCT01128023 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2019-11-21

No results posted yet for this study

Summary

Cardiovascular (CV) disease is the leading cause of death in Canada. Fifty percent of all Tc-99m used in nuclear medicine is for the diagnosis of coronary artery disease (CAD) with SPECT myocardial perfusion imaging (MPI). The reduced supply of Tc-99m requires other tracers to be investigated. Tl-201 SPECT is available but generally accepted to be inferior to Tc-99m. Rubidium (Rb-82), a nonreactor produced tracer, is believed to have superior accuracy compared to Tc-99m and Tl-201 SPECT, with 5-20 times lower radiation dose. In the U.S. Rb-82 generators have been FDA-approved since 1989 and are used increasingly for CAD diagnosis, but are still considered investigational in Canada.

Objectives: To demonstrate that Rb-82 PET MPI is i) an accurate, cost-effective alternative to Tc-99m; ii) superior to Tl-201; iii) can be implemented in multiple Canadian centres for the diagnosis and management of CAD. Short term clinical outcomes of Rb-82 will be evaluated and compared to Tc-99m and Tl-201 SPECT MPI across Canadian imaging centres.

Plan: Rb-ARMI is an innovative multidisciplinary, multi-centre imaging research initiative that builds on existing collaborative networks and Canadian industry partnership (DRAXIMAGE). Rb PET will be implemented, standardized and validated in 4 overlapping phases over 2 years, at 10 Canadian Centres.

Impact: This project meets the expected goal to "lead to clinical trial applications and clinical validation studies which compare novel radiolabeled probes with those in current practice", and to "bring a new radiopharmaceutical to the clinic" within a short time frame. Increased use of Rb-82 PET MPI has the potential to reduce the demand for Tc-99m by 10-40%, effectively increasing the available supply for other procedures, and improving the standard of care for many Canadians at risk of heart disease.

Conditions

Interventions

OTHER

Myocardial perfusion imaging using Rb-82 PET or Tc-99m or Tl SPECT

Patients will undergo a clinically indicated PET Rb-82 myocardial perfusion scan for diagnosis or risk stratification of CAD. This cohort will be matched to the SPECT perfusion database.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Rob S Beanlands, MD · Ottawa Heart Institute Research Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01128023 on ClinicalTrials.gov