Single vial freeze-dried TRODAT-1 kit: Preparation and demonstration of clinical efficacy of [99mTc]TRODAT-1 in Indian scenario

Abstract A single vial freeze-dried kit formulation for preparation of three patients׳ dose of [ 99m Tc]TRODAT-1 has been developed for early diagnosis of Parkinson׳s disease (PD). Kits were evaluated to ascertain the purity, stability and batch to batch variations. Preclinical evaluation was carried out in laboratory animals and clinical imaging was performed in human patients with PD. The labeling yield and purity of [ 99m Tc]TRODAT-1 was >90%. Swiss mice showed retention of [ 99m Tc]TRODAT-1 in the mid brain region. Clinical studies showed decreased striatal uptake with increasing severity of PD.