Clinical Utility : Japanese Clinical Trials

A multi-center, Phase lItrial involving 52 patients with previous MI, angina pectoris, AMI, cardiomyopathy, or other cardiovascular disease has been completed.16 Each patient received 185 to 851MBq (5 to 23mCi) Tc-99m-tetrofosmin during peak exercise and again at rest in either a 1-day (interval of 3 hours between injections) or a 2-day protocol SPECT images were acquired 10 to 60 minutes (early) and 90 to 210 minutes (late) post-injection.¹⁶

Image quality was invariably reported as excellent or good, and both early and late images could be used for diagnosis. Clinical usefulness was rated highly useful (29.4%), useful (54.9%), and useful to some extent (15.7%). Comparative TI-201 SPECT images were acquired in 34 patients. Total agreement was noted in 328 of 442 (74.2%) segments.¹⁶
The investigators concluded that MYOVIEW imaging provides useful information in the evaluation of ischemic heart disease and offers distinct advantages over TI-201 in terms of image quality, shortened acquisition times, and flexibility of use.¹⁶

A larger Japanese Phase III trial involving 355 patients with MI, angina pectoris, cardiomyopathy, or other cardiovascular disease also studied the clinical utility of 1- and 2-day MYOVIEW protocols.⁷ The mean Tc-99m-tetrofosmin dose used in the former protocol was 382MBq (10.3mCi) for the first injection and 671MBq (18.1mCi) for the second, while the 2-day protocol used mean doses for 549MBQ (14.8mCi) for the first injection and 517MBq (14.0mCi) for the second. Comparative TI-201 imaging was also performed.⁷

Total agreement between the two perfusion agents was found in 88% (7382 of 8418) of the segments.⁷ Importantly, the investigators determined that MYOVIEW images were of superior quality to those obtained from the TI-201 protocol. Effective clinical information was obtained from MYOVIEW images in 94% of the patients, and images were judged to be very useful or useful in 93% (331 of 355) of the cases.⁷

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