Quantitative Myocardial Perfusion Imaging Assessment by SPECT/CT

Sponsor
Centre Hospitalier Régional d'Orléans
Study ID
NCT07708805
Status
Not Yet Recruiting

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Conditions

  • Chronic Coronary Syndrome
  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Aug 25, 2026
Status verified
Jul 2026
Primary completion
Sep 25, 2027
Completion
Nov 25, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Imaging (PET and CZT-SPECT/CT) arm
    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.

Primary Outcome Measure

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. [ 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) ]

Central Contacts

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