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临床试验/NCT07708805
NCT07708805尚未招募不适用

Quantitative Myocardial Perfusion Imaging Assessment by SPECT/CT: Evaluation of Standardized Uptake Value (SUV) and Correlation With Myocardial Flow Reserve (MFR) Assessed by PET/CT

Centre Hospitalier Régional d'Orléans1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Correlation between the SPECT SUV ratio (stress SUV/rest SUV) and myocardial flow reserve measured by PET. Agreement between the2 methods will be assessed using Lin's concordance correlation coefficient, and a Bland-Altman analysis will be performed.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant has provided informed consent to participate in the study.
  • Age ≥ 18 years.
  • Patients referred for functional cardiac imaging assessment (SPECT or PET) following diagnostic coronary CT angiography (CCTA) or invasive coronary angiography demonstrating either:
  • moderate coronary atherosclerosis without significant coronary stenosis (<50% stenosis), or
  • coronary lesions for which functional cardiac imaging assessment or medical therapy is indicated.

排除标准

  • 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.
  • 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.
  • Protected adult under legal guardianship or curatorship.
  • Individual under judicial protection measures.
  • Individual deprived of liberty.
  • Individual not affiliated with a health insurance
  • Pregnant or breastfeeding woman.

结局指标

主要结局

Correlation between the SPECT SUV ratio (stress SUV/rest SUV) and myocardial flow reserve measured by PET. Agreement between the2 methods will be assessed using Lin's concordance correlation coefficient, and a Bland-Altman analysis will be performed.

时间窗: At a single time point: between imaging assessment with PET scan at J0 and imaging assessment with SPECT at J1 (within 7 days between 2 examinations)

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.

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.

时间窗: 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)

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.

次要结局

  • Diagnostic performance of SPECT SUV ratio for detecting coronary artery disease(At a single time point: between imaging assessment with PET scan at J0 and imaging assessment with SPECT at J1 (within 7 days between 2 examinations))
  • Diagnostic performance of stress SPECT SUV for detecting coronary artery disease(At a single time point: between imaging assessment with PET scan at J0 and imaging assessment with SPECT at J1 (within 7 days between 2 examinations))
  • Diagnostic performance of SPECT SUV ratio for detecting coronary artery disease(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(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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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