Evaluation of the hepatobiliary excretion of technetium-99m-MAG3 and reconstitution factors affecting radiochemical purity.

ABSTRACT

UNLABELLED Technetium-99-MAG3 is a renal tubular function agent. However, sporadic liver and gallbladder visualization have raised questions about kit stability, impurities and nonrenal routes of excretion. To address these issues, studies were conducted to optimize the labeling efficiency of the TechneScan MAG3 kit and to evaluate the hepatobiliary excretion of the MAG3 complex. METHODS: Thirty-six vials of the commercial formulation of 99mTc-MAG3 were prepared according to manufacturer's instructions and evaluated for radiochemical purity using two methods: a combination of high-performance liquid chromatography and paper chromatography (HPLC/PC); and the manufacturer's miniature chromatography system (Sep-Pak procedure). RESULTS: The labeling efficiency was significantly higher when the kit was reconstituted with 10 ml (96.6%) of saline versus 5 ml (91.4%) (p < 0.01). The radiochemical purity of the kits remained stable for up to 6 hr, but the purity determined by Sep-Pak averaged 2.5% higher than that determined by HPLC procedures (p < 0.01). Rat studies to evaluate renal and hepatobiliary elimination of MAG3 showed no difference in the %ID excreted into the urine by 60 min in all groups of animals studied. However, the %ID excreted into the bile was significantly higher for the kit formulation than the HPLC-purified MAG3, 9.9% versus 6.6% (p = 0.0475). CONCLUSION: The radiochemical purity of the TechneScan MAG3 kit can be improved by reconstituting with larger volumes. In addition, the studies in rats suggest that fasting or kit impurities may be a contributing factor to increased hepatobiliary visualization in patient studies.