Coronary Artery DiseasexSPECT MPINCT04583787
xSPECT-based Myocardial Perfusion Scintigraphy: Consistency of Functional Values and Feasibility of Myocardial Uptake Quantitation in Patients With Suspected Coronary Artery Disease
A study testing 99mTc-sestamibi myocardial perfusion SPECT and 82Rb-Chloride myocardial perfusion PET with CCTA in people with Coronary Artery Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- 99mTc-sestamibi myocardial perfusion SPECT and 82Rb-Chloride myocardial perfusion PET with CCTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Dec 2021to 28 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Allergy against adenosine
- Allergy against iodinated contrast medium
- Recent myocardial infarction (<1 month)
- Previous history of coronary revascularization
- Severe asthma
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic of Radiology & Nuclear Medicine, University Hospital of Basel
Basel, 4031
About this study
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)
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.).
- Conditions
- Coronary Artery Disease
- Being tested
- 99mTc-sestamibi myocardial perfusion SPECT, 82Rb-Chloride myocardial perfusion PET with CCTA
- 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)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-sestamibi myocardial perfusion SPECTDiagnostic test
82Rb-PET/CT with CT based coronary angiography (CCTA) as part of clinical care at Day 1
82Rb-Chloride myocardial perfusion PET with CCTADiagnostic test
stress-rest 99mTc-sestamibi myocardial perfusion SPECT, performed subsequent to 99mTc-sestamibi myocardial perfusion SPECT at Day 2
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected CAD | Experimental | Not described Receives: Diagnostic Test: 99mTc-sestamibi myocardial perfusion SPECT; Diagnostic Test: 82Rb-Chloride myocardial perfusion PET with CCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes at Day 1
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.
Measured: 120 minutes at Day 2
Secondary outcomes (5)
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.
Measured: one point assessment after interventions at day 2
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
Measured: one point assessment after interventions at day 2
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
Measured: one point assessment after interventions at day 2
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.
Measured: one point assessment after interventions at day 2
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
Measured: one point assessment after interventions at day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start7 Dec 2021
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Responsible party
- Sponsor
- Investigators
- Federico Caobelli, Dr. med., Principal investigator, Clinic of Radiology & Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583787
- Sponsor's protocol ID
- 2020-02090, qu20Caobelli
- Acronym
- xSPECT MPI
- Status last verified
- Jun 2024
- First submitted
- 28 Sep 2020
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04583787
- Acronym / sponsor ID
- xSPECT MPI / 2020-02090, qu20Caobelli
- Conditions
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected CAD | Experimental | Diagnostic Test: 99mTc-sestamibi myocardial perfusion SPECT, Diagnostic Test: 82Rb-Chloride myocardial perfusion PET with CCTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- Pregnancy
- Allergy against adenosine
- Allergy against iodinated contrast medium
- Recent myocardial infarction (<1 month)
- Previous history of coronary revascularization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-sestamibi myocardial perfusion SPECT82Rb-PET/CT with CT based coronary angiography (CCTA) as part of clinical care at Day 1 | Diagnostic test | Patients with suspected CAD |
| 82Rb-Chloride myocardial perfusion PET with CCTAstress-rest 99mTc-sestamibi myocardial perfusion SPECT, performed subsequent to 99mTc-sestamibi myocardial perfusion SPECT at Day 2 | Diagnostic test | Patients with suspected CAD |
Primary outcome
Absolute flow quantification (assessed by PET/CT)
Time frame: 60 minutes at Day 1
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)
Time frame: 120 minutes at Day 2
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.
5 secondary outcomes
Determination of uptake patterns that are suggestive for CAD
Time frame: one point assessment after interventions at day 2
Quantitative 99mTC-sestamibi uptake values of the whole myocardium
Time frame: one point assessment after interventions at day 2
Comparison of PET/CT, standard Myocardial perfusion SPECT (MPS) and new quantitative 99mTc-sestamibi xSPECT/quantitative computerized tomography (QCT) in the same patient
Time frame: one point assessment after interventions at day 2
Interobserver variability of all imaging modalities
Time frame: one point assessment after interventions at day 2
Interobserver variability of qualitative and quantitative assessments
Time frame: one point assessment after interventions at day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Caobelli, Dr. med. principal investigator
Clinic of Radiology & Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-sestamibi myocardial perfusion SPECT and 82Rb-Chloride myocardial perfusion PET with CCTA in people with Coronary Artery Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute flow quantification (assessed by PET/CT) (time frame: 60 minutes at Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.