Quantitative Myocardial Perfusion Imaging Assessment by SPECT/CT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional d'Orléans
About this trial
Myocardial perfusion single-photon emission computed tomography (SPECT) is a well-established functional imaging technique for the assessment of coronary artery disease. Recent developments in cadmium-zinc-telluride (CZT) camera technology have enabled significant reductions in acquisition time while improving image quality. Positron emission tomography (PET) myocardial imaging remains the reference standard for the quantitative assessment of myocardial blood flow (MBF) and myocardial flow reserve (MFR); however, its use is limited by high costs and restricted availability.
This exploratory study aims to evaluate the feasibility of using CZT-SPECT/CT imaging as an alternative approach by assessing the absolute quantification of myocardial tracer uptake, expressed as standardized uptake values (SUV), both at rest and during stress. The primary objective is to compare the ratio of stress-to-rest SUV obtained from SPECT with MFR values measured using PET imaging.
Patients under cardiology care at the University Hospital of Orléans who are scheduled for diagnostic coronary angiography or coronary CT angiography will be invited to participate. The study procedures will be integrated into their routine clinical workflow. On Day 0, participants will undergo a PET myocardial perfusion study using Rubidium-82, including measurement of MBF and MFR, with concomitant administration of 99mTc-tetrofosmin under pharmacological stress using the same vasodilator agent. A stress CZT-SPECT/CT acquisition will then be performed immediately after the PET scan. Within seven days of the initial evaluation, participants will undergo a rest CZT-SPECT/CT acquisition. Quantitative analysis of myocardial tracer uptake will subsequently be performed to derive SUV values.
The overall goal of this feasibility study is to generate preliminary data to support the design of a larger-scale clinical study. Ultimately, the study seeks to determine whether standard CZT-SPECT/CT imaging could provide a simpler, faster, and more widely accessible alternative to PET myocardial perfusion imaging for functional myocardial assessment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant has provided informed consent to participate in the study.
Age ≥ 18 years.
moderate coronary atherosclerosis without significant coronary stenosis (<50% stenosis), or
coronary lesions for which functional cardiac imaging assessment or medical therapy is indicated.
Disqualifiers
Severe coronary artery disease requiring prompt revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), including left main coronary artery stenosis >50% or other severe coronary lesions with FFR <0.80.
History of coronary revascularization (PCI, coronary stenting, or CABG).
Left ventricular ejection fraction (LVEF) <35%.
Contraindication to pharmacological stress testing for cardiac PET/SPECT, including severe hypotension, second- or third-degree atrioventricular block, or recent myocardial infarction.
Trial design
Design model
Single group
Treatments tested in this trial
stress SPECT/CT
Diagnostic testDuring pharmacological stress induced by a coronary vasodilator agent, an intravenous injection of 99mTc-tetrofosmin is administered for single-photon emission computed tomography (SPECT) imaging.
rest SPECT/CT
Diagnostic testA resting CZT-SPECT/CT acquisition (J1), with a minimum interval of 24 hours after the stress acquisition.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Imaging (PET and CZT-SPECT/CT) armExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Correlation between the SPECT SUV ratio (stress SUV/rest SUV) and myocardial flow reserve measured by PET. Agreement between the 2 methods will be assessed using Lin's concordance correlation coefficient, and a Bland-Altman analysis will be performed.
The outcome measure evaluates the correlation between the standardized uptake value (SUV) ratio obtained from SPECT imaging (stress SUV divided by rest SUV) and myocardial flow reserve (MFR) measured by PET. The SUV ratio is calculated as the ratio of myocardial tracer uptake normalized to injected activity under stress and rest conditions. MFR is defined as the ratio of myocardial blood flow during pharmacological stress to that at rest. The relationship between these two parameters will be assessed using correlation analysis. Additionally, concordance between methods will be evaluated using Lin's concordance correlation coefficient and Bland-Altman analysis.
Time frame
At a single time point: between imaging assessment with PET scan at Day 0 and imaging assessment with SPECT at Day 1 (within 7 days between 2 examinations)Secondary outcomes
1
Diagnostic performance of SPECT SUV ratio for detecting coronary artery disease
The diagnostic performance of the SPECT SUV ratio (stress SUV divided by rest SUV) is assessed for identifying diseased myocardial regions. Regions are classified as normal or abnormal based on anatomical reference imaging (coronary angiography or coronary CT angiography). Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) are calculated with 95% confidence intervals. The overall discriminative ability is evaluated using the area under the receiver operating characteristic curve (AUC-ROC).
Time frame
At a single time point: between imaging assessment with PET scan at Day 0 and imaging assessment with SPECT at Day 1 (within 7 days between 2 examinations)2
Diagnostic performance of stress SPECT SUV for detecting coronary artery disease
The diagnostic performance of stress SPECT SUV is assessed for identifying diseased myocardial regions. Stress SUV corresponds to myocardial tracer uptake normalized to injected activity during pharmacological stress. Regions are classified as normal or abnormal based on anatomical reference imaging (coronary angiography or coronary CT angiography). Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) are calculated with 95% confidence intervals. The discriminative ability is evaluated using the area under the receiver operating characteristic curve (AUC-ROC).
Time frame
At a single time point: between imaging assessment with PET scan at Day 0 and imaging assessment with SPECT at Day 1 (within 7 days between 2 examinations)Sponsors and contacts
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Source ClinicalTrials.gov