title: Convenient Preparation of [(68)Ga]DKFZ-PSMA-11 Using a Robust Single-Vial Kit and Demonstration of Its Clinical Efficacy.
abstract: [(68)Ga]DKFZ-PSMA-11 has proved to be an important diagnostic radiotracer for targeting prostate-specific membrane antigen (PSMA) overexpression in both recurrent prostate cancer (PC) and relevant metastatic sites. However, the widespread, routine clinical use of such a potential radiopharmaceutical demands availability of a ready-to-use kit formulation to enable convenient radiopharmaceutical preparation. Herein, we report the development of a freeze-dried kit vial for the formulation of [(68)Ga]DKFZ-PSMA-11 and its clinical use in patients using a "shake-bake-inject" methodology.
  
  
  
  The freeze-dried kit vial was developed after optimization of ligand content (PSMA-11) and pH conditions. The kit was formulated using (68)Ga from two different commercially available generators. Positron emission tomography/X-ray computed tomography (PET/CT) images of PC patients were obtained using the kit-formulated radiotracer.
  
  
  
  [(68)Ga]DKFZ-PSMA-11 was prepared in >98 % radiochemical yield and purity using the freeze-dried kit vials. Kits were optimized for the preparation of four patient doses. The clinical utility was evaluated in patients with histologically confirmed prostate cancer, and the images were of good quality as well as conforming to tumor marker and clinical expectations.
  
  
  
  The development of a simple and ready-to-use freeze-dried DKFZ-PSMA-11 kit for the preparation of Ga-68-based radiotracers constitutes a major step towards the expedition of the widespread and economical screening of PC patients.
authors.affiliation: Radiopharmaceuticals Chemistry Section, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre, Mumbai, India. drishtys77@gmail.com.
authors.forename: Drishty
authors.identifier: 0000-0003-0676-6157
authors.initials: D
authors.lastname: Satpati
authors.affiliation: Nuclear Medicine Department, Kovai Medical Center and Hospital, Coimbatore, India.
authors.forename: Ajit
authors.initials: A
authors.lastname: Shinto
authors.affiliation: Nuclear Medicine Department, Kovai Medical Center and Hospital, Coimbatore, India.
authors.forename: K K
authors.initials: KK
authors.lastname: Kamaleshwaran
authors.affiliation: Radiopharmaceuticals Chemistry Section, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre, Mumbai, India.
authors.forename: Surekha
authors.initials: S
authors.lastname: Sane
authors.affiliation: Radiopharmaceuticals Chemistry Section, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre, Mumbai, India. sharmila@barc.gov.in.
authors.forename: Sharmila
authors.initials: S
authors.lastname: Banerjee
mesh_terms: D000368:Aged; D002851:Chromatography, High Pressure Liquid; D005710:Gallium Radioisotopes; D006801:Humans; D008297:Male; D009942:Organometallic Compounds / Q000138:chemical synthesis* / Q000737:chemistry; D000072078:Positron Emission Tomography Computed Tomography; D017430:Prostate-Specific Antigen / Q000378:metabolism*; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging / Q000601:surgery; D019275:Radiopharmaceuticals / Q000138:chemical synthesis* / Q000737:chemistry; D011933:Reagent Kits, Diagnostic
chemical_list: C000622699:68Ga-DKFZ-PSMA-11; D005710:Gallium Radioisotopes; D009942:Organometallic Compounds; D019275:Radiopharmaceuticals; D011933:Reagent Kits, Diagnostic; D017430:Prostate-Specific Antigen
keywords: Freeze-dried kits; PET/CT; Prostate cancer; Prostate-specific membrane antigen (PSMA); [68Ga]DKFZ-PSMA-11