Меню
Набор скоро начнётся NCT07708805

Quantitative Myocardial Perfusion Imaging Assessment by SPECT/CT

Без фазы С лечением Coronary Artery Disease Chronic Coronary Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: stress SPECT/CT, rest SPECT/CT.
Кому может быть актуально
Состояния в реестре: Coronary Artery Disease, Chronic Coronary Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест stress 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.
  • Диагностический тест rest SPECT/CT
    A resting CZT-SPECT/CT acquisition (J1), with a minimum interval of 24 hours after the stress acquisition.

Первичные конечные точки

  • 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. [Срок оценки: 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)]
Вторичные конечные точки (2)
  • Diagnostic performance of SPECT SUV ratio for detecting coronary artery disease [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.
  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 1 центр
  • Centre Hospitalier Universitaire d'Orléans — Orléans

Публикации

  • Hyafil F, Chequer R, Sorbets E, Estellat C, Ducrocq G, Rouzet F, Alfaiate T, Regaieg H, Abtan J, Leygnac S, Milliner M, Imbert L, Burg S, Ben Azzouna R, Potier L, Laouenan C, Quintin C, Roussel R, Hartemann A, Montalescot G, Marie PY, Steg G, Le Guludec D. Head-to-head comparison of the diagnostic performances of Rubidium-PET and SPECT with CZT camera for the detection of myocardial ischemia in a PMID 30574676
  • Zhang YQ, Jiang YF, Hong L, Chen M, Zhang NN, Yang HJ, Zhou YF. Diagnostic value of cadmium-zinc-telluride myocardial perfusion imaging versus coronary angiography in coronary artery disease: A PRISMA-compliant meta-analysis. Medicine (Baltimore). 2019 Mar;98(9):e14716. doi: 10.1097/MD.0000000000014716. PMID 30817614
  • Einstein AJ, Blankstein R, Andrews H, Fish M, Padgett R, Hayes SW, Friedman JD, Qureshi M, Rakotoarivelo H, Slomka P, Nakazato R, Bokhari S, Di Carli M, Berman DS. Comparison of image quality, myocardial perfusion, and left ventricular function between standard imaging and single-injection ultra-low-dose imaging using a high-efficiency SPECT camera: the MILLISIEVERT study. J Nucl Med. 2014 Sep;55( PMID 24982439
  • Imbert L, Poussier S, Franken PR, Songy B, Verger A, Morel O, Wolf D, Noel A, Karcher G, Marie PY. Compared performance of high-sensitivity cameras dedicated to myocardial perfusion SPECT: a comprehensive analysis of phantom and human images. J Nucl Med. 2012 Dec;53(12):1897-903. doi: 10.2967/jnumed.112.107417. Epub 2012 Nov 8. PMID 23139084
  • Piekarski E, Manrique A, Rouzet F, Le Guludec D. Current Status of Myocardial Perfusion Imaging With New SPECT/CT Cameras. Semin Nucl Med. 2020 May;50(3):219-226. doi: 10.1053/j.semnuclmed.2020.02.009. Epub 2020 Mar 19. PMID 32284108

Идентификаторы

NCT: NCT07708805 · CHUO-2025-16

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗