[Phase 3 clinical study of 99mTc-MAG3 injectable, a dynamic renal imaging agent--comparison with 123I-OIH and 99mTc-DTPA].
A Phase 3 clinical study of 99mTc-mercaptoacetyl glycylglycylglycine (99mTc-MAG3) injectable was performed in 506 patients with renal and/or urinary disorders. The scintigraphic findings and renogram patterns of 99mTc-MAG3 were similar to those of 123I-OIH, and Tmax and T1/2 of the 99mTc-MAG3 renogram correlated with those of 123I-OIH (r = 0.62 and r = 0.74, respectively). The clinical efficacy of 99mTc-MAG3, evaluated by the investigators in the same patients, was superior to the efficacy of 123I-OIH and 99mTc-DTPA in 93 of 150 patients (62.0%) and 68 of 151 patients (45%), respectively. The image quality and the reliability of the scintigraphic findings with 99mTc-MAG3 were superior to those with 123I-OIH and 99mTc-DTPA, which reflect the more abundant photons of 99mTc-MAG3 than those of 123I-OIH and higher renal extraction of 99mTc-MAG3 than those of 99mTc-DTPA, respectively. Neither adverse reactions nor abnormal laboratory findings due to 99mTc-MAG3 administration were observed. These results suggest that 99mTc-MAG3 injectable is safe and a useful radiopharmaceutical for diagnosis of renal and urinary disorders.
Torizuka
K
K
Fukui Medical School.
Ishibashi
A
A
Ikekubo
K
K
Yamamoto
K
K
Nishibuchi
S
S
D000328:Adult; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D007457:Iodine Radioisotopes; D007465:Iodohippuric Acid; D007674:Kidney Diseases / Q000000981:diagnostic imaging; D008297:Male; D011866:Radioisotope Renography; D017263:Technetium Tc 99m Mertiatide; D016284:Technetium Tc 99m Pentetate; D014570:Urologic Diseases / Q000000981:diagnostic imaging*
D007457:Iodine Radioisotopes; D007465:Iodohippuric Acid; D017263:Technetium Tc 99m Mertiatide; D016284:Technetium Tc 99m Pentetate