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

Primary Purpose

Neuroendocrine Tumors

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Y90-DOTA-Tyr3-Octreotide
Sponsored by
European Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors focused on measuring beta- probe, radioguided surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • negative PET/CT; pregnancy

Sites / Locations

  • Chiara Maria Grana

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Y-90-DOTATOC

Arm Description

Patients affected by Small Intestine neuroendocrine tumors

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 3, 2020
Last Updated
March 3, 2020
Sponsor
European Institute of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT04296149
Brief Title
Beta- Probe and Surgery in GEP NET: Evaluation of a New Probe
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Institute of Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
beta- probe, radioguided surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Y-90-DOTATOC
Arm Type
Experimental
Arm Description
Patients affected by Small Intestine neuroendocrine tumors
Intervention Type
Drug
Intervention Name(s)
Y90-DOTA-Tyr3-Octreotide
Other Intervention Name(s)
Beta- emetting radioisotope
Intervention Description
Patients enrolled for surgery will receive a small amount of Y-90-DOTATOC, in order to check beta- radioactivity by the probe
Primary Outcome Measure Information:
Title
Evaluation of sensitivity of a beta- probe
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: SI NET patients, Ga-68-DOTATOC PET/CT positive, proposed for surgery Exclusion Criteria: negative PET/CT; pregnancy
Facility Information:
Facility Name
Chiara Maria Grana
City
Milano
ZIP/Postal Code
20141
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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