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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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This study is being done to compare the blood flow measurements obtained with the SPECT and PET imaging scans. Measurements such as myocardial blood flow (MBF) and myocardial flow reserve (MFR) are analyzed on PET scans. These measurements give the doctors more precise information in diagnosing heart problems. SPECT scans, with new camera technology and computer software, now have the potential to also give this additional information. The study is investigating how well the blood flow measurements from SPECT compared to PET.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single photon emission computed tomography | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single photon emission computed tomography | Other | Single photon emission computed tomography (SPECT) imaging will be done. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT | PET studies were acquired with either 82Rb or 13N-ammonia according to clinical protocol. The activity injected at both rest and stress was 10 MBq/kg (82Rb) or 5MBq/kg (ammonia). MBF was based on data acquired over 8 min (82Rb) or 4 min (ammonia). SPECT rest images were obtained for 11 min starting immediately before injection of 316 +/- 71 MBq of 99mTc-tetrofosmin. The patient returned at 45 min after injection for a 5 min static resting acquisition (corresponding to the standard time for myocardial perfusion imaging). Without repositioning, the patient was stressed using dipyridamole (0.14mg/kg/min for 5 minutes) with 11 minutes of list mode data acquired starting immediately before the injection of 1122 +/- 170 MBq of tetrofosmin. Both rest and stress injections were delivered mechanically over 30 seconds. A standard set of stress perfusion images were acquired at 45 mins after tracer injection. The myocardial blood flow obtained using SPECT was compared to the patient's PET. | From enrollment to completion of imaging was a maximum of four weeks. The average difference in acquisition dates was 19 +/- 9 days. |
| Precision of Myocardial Blood Flow Measurements Between Two SPECT Scans | SPECT myocardial blood flow (MBF) was measured and repeated at a mean interval of 18 days to assess precision of MBF measurements between the two scans. | From enrollment to completion of imaging was a maximum of four weeks. |
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Inclusion Criteria:
For all participants
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terrence Ruddy, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28611245 | Result | Wells RG, Marvin B, Poirier M, Renaud J, deKemp RA, Ruddy TD. Optimization of SPECT Measurement of Myocardial Blood Flow with Corrections for Attenuation, Motion, and Blood Binding Compared with PET. J Nucl Med. 2017 Dec;58(12):2013-2019. doi: 10.2967/jnumed.117.191049. Epub 2017 Jun 13. | |
| 32026329 | Result | Do J, Ruddy TD, Wells RG. Reduced acquisition times for measurement of myocardial blood flow with 99mTc-tetrofosmin and solid-state detector SPECT. J Nucl Cardiol. 2021 Dec;28(6):2518-2529. doi: 10.1007/s12350-020-02048-w. Epub 2020 Feb 5. |
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Enrolled patients who underwent CABG or PCI after they provided consent were excluded from the study. Enrolled patients who experienced acute myocardial infarction or acute coronary syndrome any time after the consent, were also excluded. Enrolled patients with a positive pregnancy screen prior to their research scan were excluded from the study.
Recruited 32 patients with known coronary artery disease. Patients were recruited from diagnostic clinic lists.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. single photon emission computed tomography: Single photon emission computed tomography (SPECT) imaging will be done. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. single photon emission computed tomography: Single photon emission computed tomography (SPECT) imaging will be done. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT | PET studies were acquired with either 82Rb or 13N-ammonia according to clinical protocol. The activity injected at both rest and stress was 10 MBq/kg (82Rb) or 5MBq/kg (ammonia). MBF was based on data acquired over 8 min (82Rb) or 4 min (ammonia). SPECT rest images were obtained for 11 min starting immediately before injection of 316 +/- 71 MBq of 99mTc-tetrofosmin. The patient returned at 45 min after injection for a 5 min static resting acquisition (corresponding to the standard time for myocardial perfusion imaging). Without repositioning, the patient was stressed using dipyridamole (0.14mg/kg/min for 5 minutes) with 11 minutes of list mode data acquired starting immediately before the injection of 1122 +/- 170 MBq of tetrofosmin. Both rest and stress injections were delivered mechanically over 30 seconds. A standard set of stress perfusion images were acquired at 45 mins after tracer injection. The myocardial blood flow obtained using SPECT was compared to the patient's PET. | Patients with known coronary artery disease who underwent both PET and SPECT myocardial perfusion imaging within 4 weeks. | Posted | Mean | Standard Deviation | mean residual difference in MBF | From enrollment to completion of imaging was a maximum of four weeks. The average difference in acquisition dates was 19 +/- 9 days. |
From enrollment to completion of patient imaging was four weeks.
There was no frequency threshold for reporting adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT | PET studies were acquired with either 82Rb or 13N-ammonia according to clinical protocol. The activity injected at both rest and stress was 10 MBq/kg (82Rb) or 5MBq/kg (ammonia). MBF was based on data acquired over 8 min (82Rb) or 4 min (ammonia). SPECT rest images were obtained for 11 min starting immediately before injection of 316 +/- 71 MBq of 99mTc-tetrofosmin. The patient returned at 45 min after injection for a 5 min static resting acquisition (corresponding to the standard time for myocardial perfusion imaging). Without repositioning, the patient was stressed using dipyridamole (0.14mg/kg/min for 5 minutes) with 11 minutes of list mode data acquired starting immediately before the injection of 1122 +/- 170 MBq of tetrofosmin. Both rest and stress injections were delivered mechanically over 30 seconds. A standard set of stress perfusion images were acquired at 45 mins after tracer injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terrence Ruddy | University of Ottawa Heart Institute | 6136967000 | 7267 | truddy@ottawaheart.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2018 | Aug 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 32069116 | Result | Wells RG, Radonjic I, Clackdoyle D, Do J, Marvin B, Carey C, deKemp RA, Ruddy TD. Test-Retest Precision of Myocardial Blood Flow Measurements With 99mTc-Tetrofosmin and Solid-State Detector Single Photon Emission Computed Tomography. Circ Cardiovasc Imaging. 2020 Feb;13(2):e009769. doi: 10.1161/CIRCIMAGING.119.009769. Epub 2020 Feb 11. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Suspected or known coronary artery disease | Count of Participants | Participants |
|
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| Primary | Precision of Myocardial Blood Flow Measurements Between Two SPECT Scans | SPECT myocardial blood flow (MBF) was measured and repeated at a mean interval of 18 days to assess precision of MBF measurements between the two scans. | Patients scheduled for clinically indicated SPECT myocardial perfusion studies who had an intermediate to high pretest probability of disease were 18 years of age or older and had a BMI < 40kg/m2 were recruited to the study. | Posted | Mean | Standard Deviation | % difference in MBF between SPECT scans | From enrollment to completion of imaging was a maximum of four weeks. |
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| 0 |
| 30 |
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| 30 |
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