Stabilization and multidose use of exametazime for cerebral perfusion studies

Abstract

The efficient use of exametazime for cerebral blood flow imaging is restricted by the short useful life of the reconstituted kit due to the instability of the primary complex. It is therefore recommended that 99Tcm-exametazime be used within half an hour after preparation allowing only a single patient dose to be prepared from one vial of exametazime. The shelf-life of 'cold' reconstituted exametazime has been extended by means of stannous enhancement. Freshly prepared stannous fluoride solution, 0.8 ml (5.4 micrograms SnF2), was mixed with 0.5 ml (42 micrograms) exametazime solution followed by the addition of up to 1500 MBq pertechnetate. The radiochemical purity of the chelate was 91% (S.D. 3.6%, n = 3). The rate of conversion of the primary complex (kc = 0.012 +/- 0.011 h-1) was considerably slower than the rate of degradation obtained using the recommended method of preparation (kc = 0.17 +/- 0.02 h-1). Radiochemical purity levels greater than 80% were maintained for up to 2.5 h after preparation and the level of free pertechnetate did not exceed 7%. There was only a slight deterioration of the cold reconstituted exametazime on storage of 0.3 +/- 0.1% per day. However, exametazime reconstituted up to 3 weeks previously produced more than 80% purity. The mean radiochemical purity obtained in 22 studies was 90% with a range of 81-98%. Clinical validation was performed in a blinded study of 38 patients using single photon emission computed tomography (SPECT). There was no significant difference between the images obtained using the tin enhancement method of preparation and the manufacturer's method (chi 2 = 3.62, P = 0.16).(ABSTRACT TRUNCATED AT 250 WORDS)