Cadmium-zinc-telluride (CZT) Imaging of Myocardial Blood Flow (MBF) (SPECT MBF) (SPECT MBF)
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|ClinicalTrials.gov Identifier: NCT02280941|
Recruitment Status : Recruiting
First Posted : November 2, 2014
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease||Other: single photon emission computed tomography||Not Applicable|
Absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) are calculated measurements that are obtained using positron emission tomography (PET) nuclear imaging, from a myocardial perfusion imaging (MPI) stress test, due to the advanced capabilities of the PET camera technology. These calculations provide more diagnostic and prognostic information for patients. Single photon emission computed tomography (SPECT) nuclear imaging is more widely done due to the availability and lower costs, but in the past has not been able to provide the additional information needed to perform the MBF and MFR calculations. SPECT cameras have now been developed and are in use, as well as software for the cameras that have shown that these measurements can be obtained from SPECT. The goal of this study is to compare SPECT and PET measurement of MBF and MFR and determine the reproducibility of SPECT MFR measurements.
The study will be done in 3 Phases, with recruitment done over 3 years. Phase 1 and 2 will be done over the first 2 years, with Phase 3 planned following Phases 1 and 2, in the 3rd year of recruitment.
Phase 1: patients with coronary artery disease, who are coming to the University of Ottawa Heart Institute (UOHI) for MPI stress testing will have both a PET and SPECT MPI for comparison of the measurements of MBF and MFR. The PET scan will be done as the clinical, reportable test.
Phase 2: patients with coronary artery disease, who are coming to UOHI for SPECT MPI testing will have the SPECT repeated to see how reproducible the measurements are.
Phase 3: normal, healthy volunteers will have both a PET and SPECT scan for the comparison of the measurements of MBF and MFR.
No change to any patient care will be done in Phases 1 and 2. Phase 1 and Phase 2 participants will have 1 research scan and Phase 3 participants will have 2 research scans.
Rubidium (Rb-82) Elution System Performance Data will be collected on the elution pump system, used to deliver the Rb-82 isotope, to support the system performance documentation for Health Canada Authorization.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Myocardial Blood Flow Measurements With Dedicated Solid State SPECT Camera Imaging and 99mTc-Tetrofosmin Versus PET Imaging and Rubidium-82|
|Actual Study Start Date :||October 2014|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Single photon emission computed tomography
Myocardial blood flow (MBF) measurement will be analyzed using attenuation and scatter corrected dynamic single photon emission computed tomography (SPECT) imaging data. The data will be compared to MBF obtained from positron emission tomography (PET) imaging.
Other: single photon emission computed tomography
Single photon emission computed tomography (SPECT) imaging will be done.
- Correlation [ Time Frame: 3 years ]The correlation of global and regional myocardial blood flow (MBF) measurements and calculated myocardial flow reserve (MFR) using single photon emission computed tomography (SPECT) and 99mTc-tetrofosmin (99mTc) to positron emission tomography (PET) and Rubidium-82 (Rb-82) will be determined.
- Reproducibility [ Time Frame: 3 years ]The reproducibility of global and regional myocardial blood flow (MBF) measurements and calculated myocardial flow reserve (MFR) using single photon emission computed tomography (SPECT) will be determined.
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): NCT02280941
|Contact: Clare Carey, BScN||613-696-7000 ext 15103||CCarey@ottawaheart.ca|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Contact: Clare Carey, BScN 613-696-7000 ext 15103 CCarey@ottawaheart.ca|
|Principal Investigator: Terrence Ruddy, MD|
|Principal Investigator:||Terrence Ruddy, MD||Ottawa Heart Institute Research Corporation|