Clinical experience with indigenous kit-based preparation of 68Ga-DOTATOC using commercial 68Ge/68Ga generator. (June 2018)

• Record Type: Journal Article
• Authors: Pandey, Usha; Korde, Aruna; Mukherjee, Archana; Shinto, Ajit; Kamaleswaran, K.K.; Jose, Raghi P.; Gamre, Naresh; Dash, Ashutosh
• Is Part Of: Applied radiation and isotopes. Volume 136(2018:Jun.)
• Page Start: 59
• Page End: 64
• Publication Date: 2018-06
• Subjects: 68Ge/68Ga generator -- 68Ga -- Neuroendocrine tumors -- Somatostatin -- DOTATOC kits; Radiology -- Periodicals; Radiation -- Industrial applications -- Periodicals; Nuclear chemistry -- Periodicals; Internet resource; Periodical; 660.298
• DOI: 10.1016/j.apradiso.2018.02.002
• Languages: English
• ISSNs: 0969-8043

Abstract

Abstract: Pharmaceutical grade DOTATOC kits compliant with all the quality control criteria were formulated and radiolabeled with 68 Ga in high yields. Comparison with module-based 68 Ga-DOTATOC established product equivalency. Clinical utility was evaluated in patients with histopathologically confirmed well-differentiated neuroendocrine tumors. Kit-based preparation of 68 Ga-DOTATOC could identify sites of primary and metastatic disease. PET/CT images of patients conformed to the established criteria for somatostatin imaging agents and clinical expectations. Results of this study emphasize the potential of kit-based 68 Ga-DOTATOC for PET imaging of neuroendocrine tumors. Highlights: Robust, stable, GMP complaint freeze dried kit formulation of DOTATOC. Simple, safe, user friendly kit based preparation of 68 Ga-DOTATOC. Multi-patient dose preparation using 68 GaCl3 from commercial generator. Product equivalence with module based preparation of 68 Ga-DOTATOC. Demonstration of clinical utility for PET imaging of neuroendocrine tumors in patients.