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

European Institute of Oncology

Status and phase: Completed; Phase 2

Conditions: Neuroendocrine Tumors

Treatments: Drug: Y90-DOTA-Tyr3-Octreotide

Study type: Interventional

Funder types: Other

Identifiers

NCT04296149

IEO 0388

Details and patient eligibility

About

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

Full 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

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• negative PET/CT; pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Y-90-DOTATOC

Experimental group

Description:

Patients affected by Small Intestine neuroendocrine tumors

Treatment:

Drug: Y90-DOTA-Tyr3-Octreotide