Back to resultsxSPECT-based Myocardial Perfusion Scintigraphy: Consistency of Functional Values and Feasibility of Myocardial Uptake Quantitation in Patients With Suspected Coronary Artery Disease (xSPECT MPI)
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
99mTc-sestamibi myocardial perfusion SPECT
82Rb-Chloride myocardial perfusion PET with CCTA
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring 82Rb-Chloride myocardial perfusion PET with CTCA, 99mTc-sestamibi myocardial perfusion SPECT, Myocardial perfusion SPECT, Absolute myocardial blood flow (MBF), Myocardial Standardized uptake value (SUV), CT coronary angiography (CTCA)
Eligibility Criteria
Inclusion Criteria:
- Referral to non-invasive nuclear ischemia test as part of clinical care
- Suspected coronary artery disease based on clinical symptoms
- Informed Consent as documented by signature
Exclusion Criteria:
- Pregnancy
- Allergy against adenosine
- Allergy against iodinated contrast medium
- Recent myocardial infarction (<1 month)
- Previous history of coronary revascularization
- Severe asthma
- Thyroid hyperfunction
- atrioventricular block (AV) Block > I grade
- Arrhythmic cardiopathy
- Weight >101 Kg.
- Acute or chronic renal impairment defined as Serum-Creatinine: above 1.5x upper limit of normal (ULN) and/or glomerular filtration rate (GFR) < 30 ml/min
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
- Claustrophobia
- Intake of caffeine <24 Hours before the first day of examination
- Enrolment into another study using ionizing radiation within the previous 12 months.
Sites / Locations
- Clinic of Radiology & Nuclear Medicine, University Hospital of BaselRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with suspected CAD
Arm Description
Outcomes
Primary Outcome Measures
Absolute flow quantification (assessed by PET/CT)
Consistency of quantitative parameters assessed by xSPECT compared to the "gold standard" which includes absolute flow quantification (assessed by PET/CT). The feasibility of myocardial SUV assessment by means of X-SPECT/CT will be tested by correlating the automatically calculated values with automatically calculated, PET-derived absolute blood flows. Rationale: values of quantified myocardial uptake are expected to be reliable the more they correlate with absolutely quantified myocardial blood flow in the myocardium, given the expected proportionality between uptake and subtending coronary blood flow.
presence of significant coronary stenoses (CTCA)
Consistency of quantitative parameters assessed by xSPECT compared to the "gold standard" which includes the presence of significant coronary stenoses (CTCA). Normal reference values under rest and stress in a homogeneous population without CAD will be evaluated in comparison with perfusion 82Rb-PET/CT and CT coronary angiography (CTCA) with contrast medium. Rationale: a coronary artery disease can be ruled out in patients with normal 82Rb-PET and without detectable stenoses on CTCA, thus identifying a subpopulation of normal patients, wherein reference normal values can be provided.
Secondary Outcome Measures
Determination of uptake patterns that are suggestive for CAD
Values of quantified myocardial uptake (SUV) will be identified and correlated to pathological perfusion patterns as determined by 82Rb-PET/CT.
Rationale: it is expected that patients with pathological PET imaging and reduced flow rates also present with reduced myocardial uptake of 99mTc-sestamibi.
Quantitative 99mTC-sestamibi uptake values of the whole myocardium
Quantitative 99mTC-sestamibi uptake values of the whole myocardium, analysis of the diagnostic accuracy. Values will be correlated to image-driven diagnosis of CAD Rationale: it is foreseen that a diagnosis can be provided by finding reduced myocardial uptake of 99mTc-sestamibi
Comparison of PET/CT, standard Myocardial perfusion SPECT (MPS) and new quantitative 99mTc-sestamibi xSPECT/quantitative computerized tomography (QCT) in the same patient
Comparison of sensitivity, specificity and accuracy of PET/CT, standard MPS and new quantitative 99mTc-sestamibi xSPECT/QCT in the same patient. Using the final clinical diagnosis of CAD, the diagnostic accuracy of each methodology will be tested by means of receiver operating characteristic (ROC) curves.
Rationale: it is expected that a quantitative approach can increase the diagnostic accuracy of SPECT by enhancing its sensitivity in case of globally reduced myocardial perfusion, similarly to what gained by quantitative PET
Interobserver variability of all imaging modalities
Interobserver variability of all imaging modalities. A kappa- correlation coefficient will be calculated for all three modalities.
Rationale: the quantitative data should provide higher interobserver consistency in the evaluation of patients with suspected CAD with SPECT, thus allowing for similar variability compared to quantitative PET.
Interobserver variability of qualitative and quantitative assessments
Interobserver variability of qualitative and quantitative assessments: a kappa correlation coefficient will be evaluated.
Rationale: the quantitative data should provide higher interobserver consistency in the evaluation of patients with suspected CAD
Full Information
NCT ID
NCT04583787
First Posted
September 28, 2020
Last Updated
December 7, 2021
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Siemens Corporation, Corporate Technology
1. Study Identification
Unique Protocol Identification Number
NCT04583787
Brief Title
xSPECT-based Myocardial Perfusion Scintigraphy: Consistency of Functional Values and Feasibility of Myocardial Uptake Quantitation in Patients With Suspected Coronary Artery Disease
Acronym
xSPECT MPI
Official Title
xSPECT-based Myocardial Perfusion Scintigraphy: Consistency of Functional Values and Feasibility of Myocardial Uptake Quantitation in Patients With Suspected Coronary Artery Disease (xSPECT MPI Study)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Siemens Corporation, Corporate Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the feasibility of myocardial Standardized Uptake Volume (SUV) assessment by means of X- (Single photon emission tomography) SPECT/Computed tomography (CT), to assess normal reference value under rest and stress in a homogeneous population without Coronary Artery Disease (CAD) and to assess the variation of absolute quantitative SUV measurements under rest and stress. The values will be evaluated in comparison with perfusion Positron Emission Tomography (PET)/CT (using 82Rb as perfusion tracer) and CT coronary angiography (CTCA) with contrast medium.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
82Rb-Chloride myocardial perfusion PET with CTCA, 99mTc-sestamibi myocardial perfusion SPECT, Myocardial perfusion SPECT, Absolute myocardial blood flow (MBF), Myocardial Standardized uptake value (SUV), CT coronary angiography (CTCA)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients will receive a 82Rb-PET/CT with CT based coronary angiography (CCTA) as part of clinical care. Subsequently, patients will undergo a stress-rest 99mTc-sestamibi myocardial perfusion SPECT, which will be evaluated both qualitatively and quantitatively
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with suspected CAD
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
99mTc-sestamibi myocardial perfusion SPECT
Intervention Description
82Rb-PET/CT with CT based coronary angiography (CCTA) as part of clinical care at Day 1
Intervention Type
Diagnostic Test
Intervention Name(s)
82Rb-Chloride myocardial perfusion PET with CCTA
Intervention Description
stress-rest 99mTc-sestamibi myocardial perfusion SPECT, performed subsequent to 99mTc-sestamibi myocardial perfusion SPECT at Day 2
Primary Outcome Measure Information:
Title
Absolute flow quantification (assessed by PET/CT)
Description
Consistency of quantitative parameters assessed by xSPECT compared to the "gold standard" which includes absolute flow quantification (assessed by PET/CT). The feasibility of myocardial SUV assessment by means of X-SPECT/CT will be tested by correlating the automatically calculated values with automatically calculated, PET-derived absolute blood flows. Rationale: values of quantified myocardial uptake are expected to be reliable the more they correlate with absolutely quantified myocardial blood flow in the myocardium, given the expected proportionality between uptake and subtending coronary blood flow.
Time Frame
60 minutes at Day 1
Title
presence of significant coronary stenoses (CTCA)
Description
Consistency of quantitative parameters assessed by xSPECT compared to the "gold standard" which includes the presence of significant coronary stenoses (CTCA). Normal reference values under rest and stress in a homogeneous population without CAD will be evaluated in comparison with perfusion 82Rb-PET/CT and CT coronary angiography (CTCA) with contrast medium. Rationale: a coronary artery disease can be ruled out in patients with normal 82Rb-PET and without detectable stenoses on CTCA, thus identifying a subpopulation of normal patients, wherein reference normal values can be provided.
Time Frame
120 minutes at Day 2
Secondary Outcome Measure Information:
Title
Determination of uptake patterns that are suggestive for CAD
Description
Values of quantified myocardial uptake (SUV) will be identified and correlated to pathological perfusion patterns as determined by 82Rb-PET/CT.
Rationale: it is expected that patients with pathological PET imaging and reduced flow rates also present with reduced myocardial uptake of 99mTc-sestamibi.
Time Frame
one point assessment after interventions at day 2
Title
Quantitative 99mTC-sestamibi uptake values of the whole myocardium
Description
Quantitative 99mTC-sestamibi uptake values of the whole myocardium, analysis of the diagnostic accuracy. Values will be correlated to image-driven diagnosis of CAD Rationale: it is foreseen that a diagnosis can be provided by finding reduced myocardial uptake of 99mTc-sestamibi
Time Frame
one point assessment after interventions at day 2
Title
Comparison of PET/CT, standard Myocardial perfusion SPECT (MPS) and new quantitative 99mTc-sestamibi xSPECT/quantitative computerized tomography (QCT) in the same patient
Description
Comparison of sensitivity, specificity and accuracy of PET/CT, standard MPS and new quantitative 99mTc-sestamibi xSPECT/QCT in the same patient. Using the final clinical diagnosis of CAD, the diagnostic accuracy of each methodology will be tested by means of receiver operating characteristic (ROC) curves.
Rationale: it is expected that a quantitative approach can increase the diagnostic accuracy of SPECT by enhancing its sensitivity in case of globally reduced myocardial perfusion, similarly to what gained by quantitative PET
Time Frame
one point assessment after interventions at day 2
Title
Interobserver variability of all imaging modalities
Description
Interobserver variability of all imaging modalities. A kappa- correlation coefficient will be calculated for all three modalities.
Rationale: the quantitative data should provide higher interobserver consistency in the evaluation of patients with suspected CAD with SPECT, thus allowing for similar variability compared to quantitative PET.
Time Frame
one point assessment after interventions at day 2
Title
Interobserver variability of qualitative and quantitative assessments
Description
Interobserver variability of qualitative and quantitative assessments: a kappa correlation coefficient will be evaluated.
Rationale: the quantitative data should provide higher interobserver consistency in the evaluation of patients with suspected CAD
Time Frame
one point assessment after interventions at day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Referral to non-invasive nuclear ischemia test as part of clinical care
Suspected coronary artery disease based on clinical symptoms
Informed Consent as documented by signature
Exclusion Criteria:
Pregnancy
Allergy against adenosine
Allergy against iodinated contrast medium
Recent myocardial infarction (<1 month)
Previous history of coronary revascularization
Severe asthma
Thyroid hyperfunction
atrioventricular block (AV) Block > I grade
Arrhythmic cardiopathy
Weight >101 Kg.
Acute or chronic renal impairment defined as Serum-Creatinine: above 1.5x upper limit of normal (ULN) and/or glomerular filtration rate (GFR) < 30 ml/min
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
Participation in another study with investigational drug within the 30 days preceding and during the present study,
Enrolment of the investigator, his/her family members, employees and other dependent persons,
Claustrophobia
Intake of caffeine <24 Hours before the first day of examination
Enrolment into another study using ionizing radiation within the previous 12 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Federico Caobelli, Dr. med.
Phone
+41 61 328 63 29
Email
federico.caobelli@usb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Damian Wild, Prof. Dr. med.
Phone
+41 61 328 66 83
Email
damian.wild@ubs.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Caobelli, Dr. med.
Organizational Affiliation
Clinic of Radiology & Nuclear Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Radiology & Nuclear Medicine, University Hospital of Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico Caobelli, Dr. med.
Phone
+41 61 328 63 29
Email
federico.caobelli@usb.ch
First Name & Middle Initial & Last Name & Degree
Michael Zellweger, Prof. Dr. med.
12. IPD Sharing Statement
Learn more about this trial
xSPECT-based Myocardial Perfusion Scintigraphy: Consistency of Functional Values and Feasibility of Myocardial Uptake Quantitation in Patients With Suspected Coronary Artery Disease
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