Intraoperative beta-probe for pathological tissue detection in GEP-NET patients: A prospective phase II trial

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Introduction: Accurate localisation of gastroenteropancreatic neuroendocrine tumours (GEP-NET) is essential for successful radical surgery. Radio guided surgery (RGS) is an innovative technique that may enhance lesion detection.

Aim(s): To assess the diagnostic accuracy of an intraoperative positron detector (β-Probe) using histopathology as the gold standard.

Materials and methods: This prospective, single-arm, single-centre, non-interventional phase II trial (NCT05448157) enrolled patients with histologically confirmed ileal GEP-NET; positive 68Ga-DOTATOC PET/CT (SSR-PET) within 4 weeks and age >18. Patients ineligible for radical surgery were excluded. A dose of 1.1 MBq/kg of 68Ga-DOTATOC was administered intravenously before surgery. Surgeons performed in vivo measurements using the β-Probe with handheld or DROP-IN devices. Tumour-to-background ratio (TBR) was evaluated in real-time using counts per second (CPS). SSR-PET, β-Probe, and histopathology data were compared, with ROC curve analysis used to identify the CPS cut-off with highest diagnostic accuracy. Surgeon radiation exposure was monitored using an electronic personal dosimeter (EPD).

Conference:

Presenting Author: Bertani E

Authors: Bertani E, Fumagalli Romario U, Collamati F, Ferrari M, Mattana F,

Keywords: radio guided surgery, surgery, neuroendocrine tumour, GEP-NET, gastrointestinal tumour,