Gallium-68-labeled somatostatin-receptor-targeted peptides have found widespread clinical use in Europe for positron emission tomography (PET) detection of neuroendocrine tumors, but are not FDA-approved drug products in the USA. The Expanded Access IND (Investigational New Drug exemption) provides an avenue for patient access to an unapproved drug product that is clinically needed in treatment of a serious disease. Because of a local clinical need to better define the location and extent of disease in neuroendocrine cancer patients who are candidates for multivisceral transplant, a method was developed for on-demand preparation of the 68Ga-DOTA-NOC peptide-chelate conjugate in a formulation suitable for intravenous administration. 68Ga3+ (68-minute half-life) is obtained from a long-lived commercial 68Ge/68Ga generator system in 1.5-mL 0.1M ultrapure HCL; buffered by addition of ultrapure aqueous NaOAc; and reacted with commercial cGMP DOTA-NOC conjugate (60-�g) at 80�C for 10-minutes. The 68Ga-DOTA-NOC product is then isolated by C18 solid phase extraction, recovered in 0.6-mL ethanol:saline, and diluted with additional saline prior to terminal sterilizing filtration. Under an Expanded Access IND this 68Ga-DOTA-NOC radiopharmaceutical (4.3�0.3 mCi) has been used for PET/CT imaging in seven patients. Total synthesis time, from generator elution to post-QC release of final product, averaged 47�2 minutes, with a product radiochemical purity of 98.9�0.3%. Sample PET images are shown for two patients: one with extensive, previously unknown, disease outside the abdomen; the other with disease appearing confined to the abdominal cavity.

Preparation of <sup>68</sup>Ga-DOTA-NOC for somatostatin-receptor-targeted PET/CT tumor imaging under an expanded access IND

246th National Meeting (2013)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.

Preparation of 68Ga-DOTA-NOC for somatostatin-receptor-targeted PET/CT tumor imaging under an expanded access IND

Preparation of ⁶⁸Ga-DOTA-NOC for somatostatin-receptor-targeted PET/CT tumor imaging under an expanded access IND