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

NCT ID: NCT04296149

Last Updated: 2020-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-16

Study Completion Date

2019-12-31

Brief Summary

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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

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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

Conditions

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Neuroendocrine Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Y-90-DOTATOC

Patients affected by Small Intestine neuroendocrine tumors

Group Type EXPERIMENTAL

Y90-DOTA-Tyr3-Octreotide

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Beta- emetting radioisotope

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* negative PET/CT; pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chiara Maria Grana

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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IEO 0388

Identifier Type: -

Identifier Source: org_study_id

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