title: A Freeze-Dried Kit for the Preparation of (188)Re-HEDP for Bone Pain Palliation: Preparation and Preliminary Clinical Evaluation.
abstract: (188)Re-HEDP is an established radiopharmaceutical used for pain palliation in patients with osseous metastasis. Considering commercial availability of (188)W/(188)Re generator, the accessibility to a lyophilized kit would make preparation of this radiopharmaceutical feasible at the hospital radiopharmacy having access to a generator. A protocol for the preparation of a single-vial lyophilized hydroxyethane 1,1-diphosphonic acid (HEDP) kit was developed and its consistency was checked by preparing six batches. Each sterile lyophilized kit prepared as per the protocol contained 9 mg of HEDP, 3 mg of gentisic acid, and 4 mg of SnCl2.2H2O. Randomly selected kits from all six batches were subjected to thorough quality control tests that were passed by all batches. (188)Re-HEDP could be prepared by addition of 1 mL of freshly eluted Na(188)ReO4 (up to 3700 MBq) containing 1 μmol of carrier ReO4(-) (perrhenate) and heating at 100°C for 15 minutes. (188)Re-HEDP with >95% radiochemical purity could be consistently prepared using the lyophilized kits. Sterile (188)Re-HEDP prepared using the lyophilized kit was evaluated in patients with osseous metastasis. Post-therapy images of the patient were compared with (99m)Tc-MDP bone scan and found to be satisfactory. The bone-to-background as well as tumor-to-normal bone uptake ratio was found to be significant. All patients who received therapy reported significant pain relief within a week to 10 days post-administration of (188)Re-HEDP.
authors.affiliation: 1 Radiopharmaceuticals Chemistry Section, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre , Mumbai, India .
authors.forename: Madhava B
authors.initials: MB
authors.lastname: Mallia
authors.affiliation: 2 Department of Nuclear Medicine and PET/CT, Kovai Medical Center and Hospital Limited , Coimbatore, India .
authors.forename: Ajit Sugunan
authors.initials: AS
authors.lastname: Shinto
authors.affiliation: 3 Isotope Production and Applications Division, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre , Mumbai, India .
authors.forename: Mythili
authors.initials: M
authors.lastname: Kameswaran
authors.affiliation: 2 Department of Nuclear Medicine and PET/CT, Kovai Medical Center and Hospital Limited , Coimbatore, India .
authors.forename: Koramadai Karuppusamy
authors.initials: KK
authors.lastname: Kamaleshwaran
authors.affiliation: 2 Department of Nuclear Medicine and PET/CT, Kovai Medical Center and Hospital Limited , Coimbatore, India .
authors.forename: Radhakrishnan
authors.initials: R
authors.lastname: Kalarikal
authors.affiliation: 2 Department of Nuclear Medicine and PET/CT, Kovai Medical Center and Hospital Limited , Coimbatore, India .
authors.forename: K K
authors.initials: KK
authors.lastname: Aswathy
authors.affiliation: 1 Radiopharmaceuticals Chemistry Section, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre , Mumbai, India .
authors.forename: Sharmila
authors.initials: S
authors.lastname: Banerjee
mesh_terms: D001859:Bone Neoplasms / Q000150:complications / Q000000981:diagnostic imaging / Q000532:radiotherapy*; D012968:Etidronic Acid / Q000138:chemical synthesis* / Q000737:chemistry / Q000627:therapeutic use*; D005612:Freeze Drying / Q000379:methods; D006801:Humans; D009942:Organometallic Compounds / Q000138:chemical synthesis* / Q000627:therapeutic use*; D010146:Pain / Q000209:etiology / Q000532:radiotherapy*; D010166:Palliative Care / Q000379:methods*; D019275:Radiopharmaceuticals / Q000138:chemical synthesis / Q000627:therapeutic use; D011933:Reagent Kits, Diagnostic
chemical_list: D009942:Organometallic Compounds; D019275:Radiopharmaceuticals; D011933:Reagent Kits, Diagnostic; C101598:rhenium-186 HEDP; D012968:Etidronic Acid
keywords: HEDP; Rhenium-188; bone pain palliation; lyophilized kit; osseous metastasis