NCT04296149

Beta- Probe and Surgery in GEP NET: Evaluation of a New Probe

Studio Esplorativo Monocentrico Non Controllato, in Aperto, Volto a Sviluppare e Valutare l'Applicazione di Una Tecnica Innovativa di Rimozione Radioguidata Dei Tumori Neuroendocrini Gastro-entero-pancreatici

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Radioguided surgery (RGS) with beta- radioisotopes is a novel approach focused on developing a new probe which, detecting electrons and operating with low background, provides a clearer delineation of the margins of lesions with low radiation exposition for surgeons. To validate this procedure, ex vivo specimens of tumours expressing somatostatin receptors, as small-intestine neuroendocrine (SI-NET), will be tested

Detailed description

Small Intestinal neuroendocrine patients, with a positive Ga-68-DOTATOC PET/CT, will receive a small amount of beta- radiopharmaceutical (Y-90-DOTATOC), and then operated, as clinical indicated. Tissue samples will be tested ex-vivo with a beta-probe prototype

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Y90-DOTA-Tyr3-Octreotide	Patients enrolled for surgery will receive a small amount of Y-90-DOTATOC, in order to check beta- radioactivity by the probe

Timeline

• Start date: 2017-02-16
• Primary completion: 2018-12-31
• Completion: 2019-12-31
• First posted: 2020-03-05
• Last updated: 2020-03-05

Locations

1 site across 1 country: Italy