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NCT04296149 Clinical Trial

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

Neuroendocrine Tumors Clinical Trial

— RADIONET  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04296149
Other study ID # IEO 0388
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 16, 2017
Est. completion date December 31, 2019

Study information
Verified date March 2020
Source European Institute of Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date December 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- negative PET/CT; pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy Chiara Maria Grana Milano

Sponsors (1)
Lead Sponsor Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 years
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