Procedure guidelines for PET/CT tumour imaging with 68Ga-DOTA-conjugated peptides: 68Ga-DOTA-TOC, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE

Abstract

The aim of these guidelines is to assist nuclear medicine physicians in recommending, performing, reporting and interpreting the results of somatostatin (SST) receptor PET/CT imaging using 68Ga-DOTA-conjugated peptides, analogues of octreotide, that bind to SST receptors. This imaging modality should not be regarded as the only approach to visualizing tumours expressing SST receptors or as excluding other imaging modalities useful for obtaining comparable results. The corresponding guidelines of 111In-pentetreotide scintigraphy imaging have been considered and partially integrated with this text. The same has been done with the relevant and recent literature in this field and the final result has been discussed by distinguished experts.

Experience in production of 68Ga-DOTA-NOC for clinical use under an Expanded Access IND

“…Our objective was to reliably produce the [ 68 Ga]Ga-DOTA-NOC radiopharmaceutical for clinical use in accordance with the EANNMI procedure guidelines (Virgolini, et al, 2010), while minimizing both start-up and recurring costs. While automated synthesis systems are commercially available for peptide labeling with 68 Ga, given the simplicity and scale of the required chemistry, our objectives were most effectively accomplished with the manual synthesis procedures described above.…”

“…These three targeting peptides vary slightly in amino acid sequence, resulting in variations in their receptor affinities and receptor-sub-type selectivity (Antunes, et al, 2007 ), but all appear suitable for use in clinical imaging (Virgolini, et al, 2010).…”

“…Gallium-68-labeled somatostatin-receptor-targeted peptides, such as [ 68 (Virgolini, et al, 2010;Pettinato, et al, 2008;, but none are FDA-approved drug products in the USA.…”

The future of nuclear medicine imaging of neuroendocrine tumors: on a clear day one might see forever…

“…Ga-SMS-R-PET, although four peptides are currently in use (DOTATOC, DOTANOC, DOTATATE and HA-DOTATATE), no marketing authorization for Ge/Ga generators or 68 Ga-DOTA-peptides exists [16]. These peptides are therefore prepared according to the Good Radiopharmacy Practice.…”

“…edqm.eu/medias/fichiers/index_english1.pdf), the EANM guidelines only regulate the general aspects of the procedure. Specific items such as acquisition parameters, administered activity and SUV measurement have been delegated to individual centers [16].…”