Radio-guided surgery with a new generation β-probe for radiolabelled somatostatin analogue, in patients with small intestinal neuroendocrine tumors – A Phase II surgical trial

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Introduction: Radio-guided surgery (RGS) proved to be promising in neuroendocrine tumors (NETs). Previous studies showed high sensitivity but low specificity using gamma probes to detect radiation emitted by radio-labelled somatostatin analogues.

Aim(s): To evaluate the diagnostic accuracy of a new generation intra-operative positron detector (β-Probe) to detect small-intestinal neuroendocrine tumors (SI-NET) locations, using histopathology of the surgical specimen as standard of truth.

Materials and methods: This is a prospective, single-arm, single-centre, phase 2 trial (NCT05448157). Inclusion criteria were: 1) proven SI-NET; 2) baseline 68Ga-DOTATOC positron emission tomography/computed tomography performed within 4 weeks; 3) age≥18 years-old; 4) willing to sign informed consent form. Exclusion criteria were: 1) patients unfit for surgery; 2) negative somatostatin receptor imaging. Patients were intravenously injected with of 1.1 MBq/Kg of 68Ga-DOTA-TOC in the surgery theatre, 10 minutes prior to surgery. In-vivo measurements with a β-probe were performed. Main outcomes and measures were sensitivity and specificity in a per-lesion analysis as well as safety of procedure.

Conference:

Presenting Author: Danieli M

Authors: Bertani E, Fumagalli Romario U, Collamati F, Mattana F, Fazio N,

Keywords: Radio-guided surgery, small-intestinal neuroendocrine tumor, small-intestinal resection, beta-probe, radiolabelled somatostatine analogues, surgery, lymphadenectomy,