An interventional study of stress SPECT/CT and rest SPECT/CT in Coronary Artery Disease and Chronic Coronary Syndrome, sponsored by Centre Hospitalier Régional d'Orléans. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Diagnostic
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.
Coronary artery disease is a major cause of morbidity and mortality worldwide and requires accurate diagnostic and functional assessment to guide patient management. Non-invasive myocardial perfusion imaging plays a central role in the evaluation of ischemia and risk stratification. Single-photon emission computed tomography (SPECT) is widely used for this purpose due to its availability, established clinical utility, and integration into routine cardiology practice.
Recent technological advancements have led to the development of cadmium-zinc-telluride (CZT) SPECT cameras, which offer significant improvements over conventional systems. These improvements include higher sensitivity, better spatial resolution, and faster acquisition times, allowing more efficient imaging workflows and enhanced patient comfort. Despite these advances, conventional SPECT imaging is primarily based on relative perfusion assessment and does not routinely provide absolute quantification of myocardial blood flow.
Positron emission tomography (PET) myocardial perfusion imaging is currently considered the reference standard for the non-invasive quantification of myocardial blood flow (MBF) and myocardial flow reserve (MFR). This technique enables absolute measurement of myocardial perfusion under rest and stress conditions and provides important diagnostic and prognostic information. However, the widespread use of PET is limited by several factors, including high costs, the need for dedicated infrastructure, and limited availability of radiotracers such as Rubidium-82. As a result, access to PET imaging remains restricted in many clinical settings.
In this context, there is a growing interest in developing alternative approaches that could provide quantitative functional information using more accessible imaging modalities. CZT-SPECT imaging has the potential to enable absolute quantification of myocardial tracer uptake expressed as standardized uptake values (SUV). This approach may allow the calculation of a stress-to-rest uptake ratio, which could serve as an indirect marker of myocardial perfusion reserve and potentially approximate the information provided by MFR measured with PET.
The present study is designed as a prospective, single-center, pilot, study conducted at the University Hospital of Orléans. The primary objective is to assess the feasibility of obtaining quantitative SUV measurements using CZT-SPECT and to compare the resulting stress-to-rest SUV ratios with MFR values derived from PET imaging in the same patients. This comparison aims to evaluate the potential of CZT-SPECT as a surrogate method for functional myocardial assessment.
Eligible participants include adult patients under cardiology follow-up who are referred for diagnostic coronary angiography or coronary computed tomography angiography as part of their standard clinical care. Patients will be informed about the study during their cardiology consultation and will be invited to participate on a voluntary basis. Written informed consent will be obtained prior to inclusion. All enrolled participants will undergo the same study procedures without randomization or group allocation. Patients eligible for inclusion are those identified during routine clinical care, either following coronary computed tomography angiography or invasive coronary angiography, presenting with moderate coronary stenosis (typically between 50% and 70%) for which further functional evaluation is indicated to guide clinical management. Patients with severe coronary disease requiring immediate revascularization are not eligible for participation.
The imaging protocol has been designed to align with routine clinical practice while enabling direct comparison between PET and SPECT-derived measurements. On Day 0 (J0), participants will undergo a PET myocardial perfusion study using Rubidium-82. This examination includes both rest and pharmacological stress phases using a coronary vasodilator agent, allowing the measurement of MBF and the calculation of MFR.
During PET imaging, participants will receive a concomitant injection of 99mTc-tetrofosmin under the same pharmacological stress conditions to ensure comparable hemodynamic states. A stress CZT-SPECT/CT acquisition will then be performed after the PET acquisition under the same pharmacological stress conditions, enabled by the short half-life of the PET radiotracer (Rubidium-82). This sequential approach avoids the need for repeated pharmacological stress, minimizes variability between imaging modalities and allows direct comparison of functional parameters obtained during similar physiological conditions.
Within seven days after the initial visit (J0), participants will undergo a second CZT-SPECT/CT acquisition at rest (second visit = J1). This delayed rest imaging allows measurement of baseline myocardial tracer uptake. Quantitative image analysis will be performed to derive SUV values for both stress and rest acquisitions. From these measurements, a stress-to-rest SUV ratio will be calculated for each participant.
As a single-group study, all participants serve as their own controls, allowing within-subject comparison between PET-derived myocardial flow reserve and SPECT-derived SUV ratios. The study aims to assess feasibility and generate preliminary data to support future larger-scale investigations.
The study will evaluate feasibility endpoints, including the ability to perform standardized quantitative acquisitions, the success rate of SUV calculation, and the quality of the imaging data obtained. In addition, exploratory analyses will assess the relationship between SUV ratios derived from CZT-SPECT and MFR values obtained from PET. These analyses will provide preliminary information on the potential agreement and clinical relevance of this approach.
The results of this study are intended to generate preliminary evidence to support the design of a subsequent larger-scale clinical trial. The long-term objective is to determine whether CZT-SPECT imaging with SUV quantification could represent a simplified, faster, and more widely available alternative to PET myocardial perfusion imaging for the assessment of myocardial function and coronary physiology in routine clinical practice.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 30 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
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Patients referred for functional cardiac imaging assessment (SPECT or PET) following diagnostic coronary CT angiography (CCTA) or invasive coronary angiography demonstrating either:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study including patients with chronic coronary syndrome and intermediate coronary lesions requiring functional assessment. At inclusion (J0), participants receive a myocardial perfusion PET scan using Rubidium-82 for the quantification of myocardial blood flow (MBF) and myocardial flow reserve (MFR). During pharmacological stress induced by a coronary vasodilator agent, an additional intravenous injection of 99mTc-tetrofosmin is administered for SPECT imaging. A stress CZT-SPECT/CT acquisition is performed immediately following the PET scan under same stress conditions. Within a maximum of 7 days after the initial imaging session, participants return for a resting CZT-SPECT/CT acquisition (J1), with a minimum interval of 24 hours after the stress acquisition. Hemodynamic parameters are recorded during imaging to allow assessment of potential variability. Quantitative analysis of myocardial perfusion is performed using dedicated software to derive SUV from SPECT imaging.
Diagnostic Test: stress SPECT/CT · Diagnostic Test: rest SPECT/CT
During pharmacological stress induced by a coronary vasodilator agent, an intravenous injection of 99mTc-tetrofosmin is administered for single-photon emission computed tomography (SPECT) imaging.
A resting CZT-SPECT/CT acquisition (J1), with a minimum interval of 24 hours after the stress acquisition.
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)
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)
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)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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