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

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

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chiara Maria Grana

Milan, 20141, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

negative PET/CT; pregnancy

Treatment and study plan

Y90-DOTA-Tyr3-Octreotide

Drug

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

Other names: Beta- emetting radioisotope

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Acronym: RADIONET

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Mar 5, 2020
Registry last updated: Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed