A Phase III Prospective, Multicenter, Open-label Study to Assess Diagnostic Efficacy of a Novel 18F-labelled Tracer, SYN2, for Positron Emission Tomography in Subjects with Suspected Coronary Artery Disease

Conditions

Coronary Artery Disease

Brief summary

Diagnostic performance in terms of sensitivity and specificity of qualitative expert assessment of SYN2 PET MPI against the reference standard.

Detailed description

Diagnostic performance in terms of the area under the receiver operating characteristics (AUC-ROC) of quantitative analysis of SYN2 PET MPI against the reference standard in diagnosis of significant CAD. AUC ROC will be estimated by the trapezoidal rule., Adverse events and reportable serious adverse rates during the resting study as defined by the NCI Common Toxicity Criteria for Adverse Events; CTCAE v.5.0, including but not limited to changes in laboratory parameters, ECG parameters, physical examination, and vital signs., Diagnostic performance in terms of sensitivity and specificity of qualitative expert assessment of SYN2 PET MPI in detection of CAD against the reference standard of ICA alone and CAD defined by >70% stenosis in a major branch in subjects with suspected CAD., Diagnostic performance in terms of the area under the receiver operating characteristics (AUC-ROC) of quantitative perfusion analysis of SYN2 PET MPI in the detection of significant CAD by ICA alone and CAD defined by >70% stenosis in a major branch.

Related papers

No related papers found yet.

Interventions

DRUGAdenosine 6 mg/2 ml solution for injection

DRUGRapiscan 400 microgram solution for injection

DRUGSYN2

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Diagnostic performance in terms of sensitivity and specificity of qualitative expert assessment of SYN2 PET MPI against the reference standard.	—

Secondary

Measure	Time frame
Diagnostic performance in terms of the area under the receiver operating characteristics (AUC-ROC) of quantitative analysis of SYN2 PET MPI against the reference standard in diagnosis of significant CAD. AUC ROC will be estimated by the trapezoidal rule., Adverse events and reportable serious adverse rates during the resting study as defined by the NCI Common Toxicity Criteria for Adverse Events; CTCAE v.5.0, including but not limited to changes in laboratory parameters, ECG parameters, physical examination, and vital signs., Diagnostic performance in terms of sensitivity and specificity of qualitative expert assessment of SYN2 PET MPI in detection of CAD against the reference standard of ICA alone and CAD defined by >70% stenosis in a major branch in subjects with suspected CAD., Diagnostic performance in terms of the area under the receiver operating characteristics (AUC-ROC) of quantitative perfusion analysis of SYN2 PET MPI in the detection of significant CAD by ICA alone and CAD d	—

Measure

Time frame

Diagnostic performance in terms of the area under the receiver operating characteristics (AUC-ROC) of quantitative analysis of SYN2 PET MPI against the reference standard in diagnosis of significant CAD. AUC ROC will be estimated by the trapezoidal rule., Adverse events and reportable serious adverse rates during the resting study as defined by the NCI Common Toxicity Criteria for Adverse Events; CTCAE v.5.0, including but not limited to changes in laboratory parameters, ECG parameters, physical examination, and vital signs., Diagnostic performance in terms of sensitivity and specificity of qualitative expert assessment of SYN2 PET MPI in detection of CAD against the reference standard of ICA alone and CAD defined by >70% stenosis in a major branch in subjects with suspected CAD., Diagnostic performance in terms of the area under the receiver operating characteristics (AUC-ROC) of quantitative perfusion analysis of SYN2 PET MPI in the detection of significant CAD by ICA alone and CAD d

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Countries

Finland, Germany, Italy, Netherlands, Poland

Outcome results

None listed