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The main objective of this study has been achieved. Following internal discussions, the sponsor has decided to terminate this study early.
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Compare the diagnostic certainty of MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI.
This trial is a single-arm, single-center, open-label, self-controlled study. Patients with suspected or known stable coronary artery disease who have previously undergone coronary CTA showing 30%-80% stenosis in any coronary vessel, or mild to moderate stenosis, will be enrolled and sequentially undergo MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI. Imaging will be independently and blindly read by expert readers for both MIBI SPECT MPI and XTR004 PET MPI. The diagnostic certainty of the reading results from the two imaging modalities will then be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XTR004 MPI PET & MIBI SPECT MPI | Experimental | Patients with suspected or known stable coronary artery disease who have previously undergone coronary CTA showing 30%-80% stenosis in any coronary vessel, or mild to moderate stenosis, will be enrolled and sequentially undergo MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XTR004 | Drug | At rest: IV bolus injection of XTR004 with a dose range of 2.0-2.5 mCi At stress: IV infusion of adenosine at a rate of 140 μg/kg/min. IV bolus injection of XTR004 with a dose range of 6.0-7.5 mCi. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of vessel-level diagnostic certainty for XTR004 PET/MIBI SPECT myocardial perfusion imaging. | Day1-7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | Beijing Municipality | 100176 | China |
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