Quantitative Myocardial Perfusion Imaging Assessment by SPECT/CT

NCT07708805 | Not Yet Recruiting

• 1 other identifier: CHUO-2025-16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Chronic Coronary Syndrome

Keywords

Myocardial perfusion SPECT; myocardial flow reserve; Standardized Uptake Value

Outcome Measures

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.

  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 (2)

• 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)

Study Arms (1)

Imaging (PET and CZT-SPECT/CT) arm

EXPERIMENTAL

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

Interventions

stress SPECT/CT DIAGNOSTIC_TEST

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.

Imaging (PET and CZT-SPECT/CT) arm

rest SPECT/CT DIAGNOSTIC_TEST

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

Imaging (PET and CZT-SPECT/CT) arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Centre Hospitalier Universitaire d'Orléans

Orléans, Loiret, 45067, France

Location

Related Publications (5)

• 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 population of women and overweight individuals. J Nucl Cardiol. 2020 Jun;27(3):755-768. doi: 10.1007/s12350-018-01557-z. Epub 2018 Dec 20.

  PMID: 30574676 BACKGROUND

• 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 BACKGROUND

• 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(9):1430-7. doi: 10.2967/jnumed.114.138222. Epub 2014 Jun 30.

  PMID: 24982439 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Matthieu BAILLY, Professor

  Centre Hospitalier Régional d'Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthieu BAILLY, Professor

CONTACT

0238575078; matthieu.bailly@chu-orleans.fr

Fanny LOUAT

CONTACT

0238744295; fanny.louat@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a prospective, single-center, pilot study enrolling 30 participants with chronic coronary syndrome and intermediate coronary lesions requiring functional assessment. 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 for which further functional evaluation is indicated to guide clinical management. All participants will undergo myocardial perfusion PET, which is considered the reference method and is part of routine clinical practice at the study site. Participants will undergo stress SPECT imaging using a CZT camera performed immediately after the PET acquisition under the same pharmacological stress. A second visit will be scheduled following the initial imaging session to perform a resting CZT-SPECT acquisition.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): September 25, 2027
• Study Completion (Estimated): November 25, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

FR (1)