[Clinical usefulness of 99mTc-MAG3--a multicenter phase III study]

A multicenter clinical trial of 99mTc-mercaptoacetylglycylglycylglycine (99mTc-MAG3), a new 99mTc-labeled renal scintigraphic and renographic dynamic functional agent, was performed to evaluate its clinical usefulness at 24 hospitals. The study was performed as a phase III clinical trial and total 357 patients with renal or urinary disorders were examined. There was no adverse reactions in all patients therefore administration agent was judged to be safe by the investigators. 99mTc-MAG3 was proved and concluded to have a superior effectiveness by the investigators in all 347 patients, and by the committee composed of eight representative investigators in 346 patients (99.7%). 99mTc-MAG3 gives a good quality of images of renal, perfusion phase and function-excretory phase as well as functional informations in comparison with 123I-OIH. The committee decided that 99mTc-MAG3 had a superior effectiveness than 123I-OIH in 147 out of 153 cases (96.1%). It is concluded that 99mTc-MAG3 is a safe and effective radiopharmaceutical for routine use in diagnosis of renal dynamic function.