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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2018

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

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Y-90-DOTATOC
    • Patients affected by Small Intestine neuroendocrine tumors

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of sensitivity of a beta- probe
    • Time Frame: 2 years
    • after receiving a small amount of radioactivity, patients will be operated and an evaluation of radioactivity on surgical specimens will be evaluated

Participating in This Clinical Trial

Inclusion Criteria

  • SI NET patients, Ga-68-DOTATOC PET/CT positive, proposed for surgery

Exclusion Criteria

  • negative PET/CT; pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • European Institute of Oncology
  • Provider of Information About this Clinical Study
    • Sponsor

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