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

Phase 2
Completed
Conditions
Neuroendocrine Tumors
Interventions
Drug: Y90-DOTA-Tyr3-Octreotide
Registration Number
NCT04296149
Lead Sponsor
European Institute of Oncology
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
5
Inclusion Criteria
  • SI NET patients, Ga-68-DOTATOC PET/CT positive, proposed for surgery
Exclusion Criteria
  • negative PET/CT; pregnancy

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Y-90-DOTATOCY90-DOTA-Tyr3-OctreotidePatients affected by Small Intestine neuroendocrine tumors
Primary Outcome Measures
NameTimeMethod
Evaluation of sensitivity of a beta- probe2 years

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
NameTimeMethod

Trial Locations

Locations (1)

Chiara Maria Grana

🇮🇹

Milano, Italy

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