xSPECT-based Myocardial Perfusion Scintigraphy: Consistency of Functional Values and Feasibility of Myocardial Uptake Quantitation in Patients With Suspected Coronary Artery Disease

NCT04583787 | Completed

• 1 other identifier: 2020-02090, qu20Caobelli
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.).

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)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  120 minutes at Day 2

Secondary Outcomes (5)

• Determination of uptake patterns that are suggestive for CAD

  one point assessment after interventions at day 2

• Quantitative 99mTC-sestamibi uptake values of the whole myocardium

  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

  one point assessment after interventions at day 2

• Interobserver variability of all imaging modalities

  one point assessment after interventions at day 2

• Interobserver variability of qualitative and quantitative assessments

  one point assessment after interventions at day 2

Study Arms (1)

Patients with suspected CAD

EXPERIMENTAL

Diagnostic Test: 99mTc-sestamibi myocardial perfusion SPECT; Diagnostic Test: 82Rb-Chloride myocardial perfusion PET with CCTA

Interventions

99mTc-sestamibi myocardial perfusion SPECT DIAGNOSTIC_TEST

82Rb-PET/CT with CT based coronary angiography (CCTA) as part of clinical care at Day 1

Patients with suspected CAD

82Rb-Chloride myocardial perfusion PET with CCTA DIAGNOSTIC_TEST

stress-rest 99mTc-sestamibi myocardial perfusion SPECT, performed subsequent to 99mTc-sestamibi myocardial perfusion SPECT at Day 2

Patients with suspected CAD

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Clinic of Radiology & Nuclear Medicine, University Hospital of Basel

Basel, 4031, Switzerland

Location

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

• Federico Caobelli, Dr. med.

  Clinic of Radiology & Nuclear Medicine

  PRINCIPAL INVESTIGATOR

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: 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

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 12, 2020
• Study Start: December 7, 2021
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

CH (1)