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

European Institute of Oncology5 enrolled

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Neuroendocrine Tumors

Interventions

Y90-DOTA-Tyr3-OctreotideDRUG

Patients enrolled for surgery will receive a small amount of Y-90-DOTATOC, in order to check beta- radioactivity by the probe

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * SI NET patients, Ga-68-DOTATOC PET/CT positive, proposed for surgery Exclusion Criteria: * negative PET/CT; pregnancy

Locations (1)

Chiara Maria Grana

Milan, Italy

Outcomes

Primary Outcomes

Evaluation of sensitivity of a beta- probe

after receiving a small amount of radioactivity, patients will be operated and an evaluation of radioactivity on surgical specimens will be evaluated

Time frame: 2 years

Data from ClinicalTrials.gov

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