Ignite Creation Date:
2024-05-05 @ 10:31 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01128023
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2010-05-05
Brief Title:
Rubidium-82 - An Alternative Radiopharmaceutical for Myocardial ImagingRb-ARMI
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
Rubidium-82 - An Alternative Radiopharmaceutical for Myocardial ImagingRb-ARMI
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Rb-ARMI
Brief 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 US 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
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
Detailed Description:
Rationale Cardiovascular CV disease is the leading cause of death in Canada Half of all the 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 While Tl-201 SPECT is available it is generally accepted to be inferior to the Tc-99m tracers low specificity may prompt further testing and increase costs Rubidium Rb-82 PET MPI is believed to have superior accuracy compared to Tc-99m and Tl-201 and 5-20 times lower radiation dose Rb-82 is produced in a generator from the cyclotron-produced non-reactor parent isotope Sr-82 In the US Rb-82 generators have been FDA-approved since 1989 Rb-82 PET MPI has been reimbursed in the US since 1995 and is used increasingly for CAD diagnosis but is still considered investigational in Canada
Objectives Primary To demonstrate that Rb-82 PET MPI is i an accurate alternative to Tc-99m SPECTii is superior to Tl-201 iii can be implemented in multiple Canadian centres for diagnosis and management of CAD Secondary To evaluate short-term clinical outcomes and cost-effectiveness of Rb-82 PET MPI for diagnosis and management of CAD compared i to Tc-99m and Tl-201 MPI and ii across imaging centres
Hypotheses 1 Rubidium MPI can be standardized with highly repeatable interpretation across multiple Canadian centres using current 3D PET and 3D PETCT imaging technology
2-A Rubidium PET MPI has superior accuracy compared to Tl-201 SPECT MPI using invasive coronary angiography ICA as the gold-standard for diagnosis of CAD reference centre A - Ottawa 2-B Rubidium PET MPI has comparable accuracy to Tc-99m SPECT MPI reference centre B - Quebec 3 Rubidium PET MPI has similar non-inferior accuracy across additional Canadian imaging centres compared to the primary imaging centres 4-A Rubidium PET MPI is cost-effective compared to Tc-99m and Tl-201 SPECT MPI in the diagnosis and management of CAD in terms of tracer costs and down-stream resource utilization such as ICA
4-B Rubidium PET MPI improves short-term clinical outcomes measured at 6 months compared to Tc-99m or Tl-201 SPECT MPI in the management of CAD in terms of adverse cardiac events including cardiac death nonfatal MI late revascularization and cardiac hospitalization 4-C Site-specific attributes will impact resource utilization and local Rb-82 PET costs
Research Plan Rb-ARMI is an innovative multidisciplinary multi-centre imaging research initiative that builds on existing collaborative networks ICT IMAGE-HF CAIN CADRE and Canadian industry partnership DRAXIMAGE Rb-82 PET will be implemented standardized and validated in 4 overlapping phases over 2 years in up to 10 centres across Canada including Ottawa Quebec City Montreal Sherbrooke Toronto Hamilton London Thunder Bay Halifax and Edmonton
Phase 1 is a knowledge translation and standardization phase 0-6 months Qualifying scans using cardiac phantoms will be performed to standardize imaging protocols across centres Site training and co-reading of an initial series of scans from each centre will be performed by the reference site Ottawa to confirm low inter-operator variability 5 in interpretation sum stress score and sum difference score
Phase 2 is a matched-cohort comparative accuracy study months 3-20 In the reference centres pre-test likelihood extent of CAD will be assessed in patients referred for assessment of ischemia N200 undergoing dipyridamole Rb-82 PET MPI and coronary angiography ICA within 6 months These patients will be used to identify a matched group undergoing Tl-201 SPECT to compare accuracy in 2A A similar study will be performed to compare Rb-82 PET with Tc-99m SPECT MPI in centre B the site most ready to start Rb-82 PET MPI using the same propensity-matched cohort design in 2B All 800 angiography studies 600 in phase 3 will be co-read by the core lab in Montreal
Phase 3 tests whether the implementation of Rb-82 PET across the additional imaging centres in Canada can achieve comparable accuracy again using ICA as the gold-standard in N600 patients months 4-20
Phase 4 is a cost-effectiveness study to evaluate short-term resource utilization RU cost and outcomes at 6-month follow-up for Rb-82 PET vs SPECT MPI centres A and B in 4A and 4B N1000 Rb-82 PET in additional Canadian sites vs the primary centres in 4C N1000 RU will be measured during follow up and unit costs estimated Analysis will estimate incremental costs associated with each of the outcomes within the composite endpoint as well as costs associated specifically with the imaging and subsequent diagnostic tests Cost-effectiveness analysis will be undertaken in accordance with Canadian guidelines for economic evaluations Database review follow-up completion data analysis and manuscript preparation will be completed in the final 6 months of the study
Impact The project meets the expected goal of the RFA 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
Objectives Primary To demonstrate that Rb-82 PET MPI is i an accurate alternative to Tc-99m SPECTii is superior to Tl-201 iii can be implemented in multiple Canadian centres for diagnosis and management of CAD Secondary To evaluate short-term clinical outcomes and cost-effectiveness of Rb-82 PET MPI for diagnosis and management of CAD compared i to Tc-99m and Tl-201 MPI and ii across imaging centres
Hypotheses 1 Rubidium MPI can be standardized with highly repeatable interpretation across multiple Canadian centres using current 3D PET and 3D PETCT imaging technology
2-A Rubidium PET MPI has superior accuracy compared to Tl-201 SPECT MPI using invasive coronary angiography ICA as the gold-standard for diagnosis of CAD reference centre A - Ottawa 2-B Rubidium PET MPI has comparable accuracy to Tc-99m SPECT MPI reference centre B - Quebec 3 Rubidium PET MPI has similar non-inferior accuracy across additional Canadian imaging centres compared to the primary imaging centres 4-A Rubidium PET MPI is cost-effective compared to Tc-99m and Tl-201 SPECT MPI in the diagnosis and management of CAD in terms of tracer costs and down-stream resource utilization such as ICA
4-B Rubidium PET MPI improves short-term clinical outcomes measured at 6 months compared to Tc-99m or Tl-201 SPECT MPI in the management of CAD in terms of adverse cardiac events including cardiac death nonfatal MI late revascularization and cardiac hospitalization 4-C Site-specific attributes will impact resource utilization and local Rb-82 PET costs
Research Plan Rb-ARMI is an innovative multidisciplinary multi-centre imaging research initiative that builds on existing collaborative networks ICT IMAGE-HF CAIN CADRE and Canadian industry partnership DRAXIMAGE Rb-82 PET will be implemented standardized and validated in 4 overlapping phases over 2 years in up to 10 centres across Canada including Ottawa Quebec City Montreal Sherbrooke Toronto Hamilton London Thunder Bay Halifax and Edmonton
Phase 1 is a knowledge translation and standardization phase 0-6 months Qualifying scans using cardiac phantoms will be performed to standardize imaging protocols across centres Site training and co-reading of an initial series of scans from each centre will be performed by the reference site Ottawa to confirm low inter-operator variability 5 in interpretation sum stress score and sum difference score
Phase 2 is a matched-cohort comparative accuracy study months 3-20 In the reference centres pre-test likelihood extent of CAD will be assessed in patients referred for assessment of ischemia N200 undergoing dipyridamole Rb-82 PET MPI and coronary angiography ICA within 6 months These patients will be used to identify a matched group undergoing Tl-201 SPECT to compare accuracy in 2A A similar study will be performed to compare Rb-82 PET with Tc-99m SPECT MPI in centre B the site most ready to start Rb-82 PET MPI using the same propensity-matched cohort design in 2B All 800 angiography studies 600 in phase 3 will be co-read by the core lab in Montreal
Phase 3 tests whether the implementation of Rb-82 PET across the additional imaging centres in Canada can achieve comparable accuracy again using ICA as the gold-standard in N600 patients months 4-20
Phase 4 is a cost-effectiveness study to evaluate short-term resource utilization RU cost and outcomes at 6-month follow-up for Rb-82 PET vs SPECT MPI centres A and B in 4A and 4B N1000 Rb-82 PET in additional Canadian sites vs the primary centres in 4C N1000 RU will be measured during follow up and unit costs estimated Analysis will estimate incremental costs associated with each of the outcomes within the composite endpoint as well as costs associated specifically with the imaging and subsequent diagnostic tests Cost-effectiveness analysis will be undertaken in accordance with Canadian guidelines for economic evaluations Database review follow-up completion data analysis and manuscript preparation will be completed in the final 6 months of the study
Impact The project meets the expected goal of the RFA 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 211897 | OTHER | Canadian Institutes of Health Research | None |