Development and validation of a kit formulation of [68Ga]Ga-P15-041 as a bone imaging agent.
Appl Radiat Isot
; 169: 109485, 2021 Mar.
Article
in En
| MEDLINE
| ID: mdl-33360838
ABSTRACT
One of the commonly performed studies in nuclear medicine are bone scans with [99mTc]Tc-methylene diphosphonate (MDP) for detecting various bone lesions, including cancer metastasis. The recent emergence of commercially available 68Ge/68Ga radionuclide generators makes it possible to provide 68Ga-labelled bisphosphonates as positron emission tomography (PET) tracers for bone imaging. Preliminary human studies suggested that [68Ga]Ga-HBED-CC-BP ([68Ga]Ga-P15-041) in conjunction with PET/computed tomography (CT) showed accumulation in known bone lesions, fast clearance from blood and soft tissue, and an ability to provide high contrast images. A simple and efficient lyophilized P15-041 kit formulation for the rapid production of [68Ga]Ga-P15-041 with excellent radiochemical purity (RCP) under ambient temperature without the need for purification is described. It is demonstrated that clinical doses of [68Ga]Ga-P15-041 can be prepared manually within minutes with an excellent purity (> 90%) and readily meet the dose release criteria. When [68Ga]Ga-P15-041 was evaluated in a patient with cancer, the imaging agent clearly showed accumulations in multiple lesions. In conclusion, [68Ga]Ga-P15-041, prepared by a lyophilized kit, might be an excellent bone imaging agent for widespread clinical application.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Bone Neoplasms
/
Radiopharmaceuticals
/
Gallium Radioisotopes
Limits:
Humans
Language:
En
Journal:
Appl Radiat Isot
Journal subject:
MEDICINA NUCLEAR
/
SAUDE AMBIENTAL
Year:
2021
Document type:
Article
Affiliation country:
China