Evaluation of a new surgical technique in neuroendocrine tumors

An open label, single-center, not controlled, exploratory study to develop and evaluate the application of a new technique of radioguided surgery in gastro-entero-pancreatic neuroendocrine tumors (RADIONET) - nd

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005202-10-IT

Enrollment

Registered

2021-01-28

Start date

2016-07-06

Completion date

Unknown

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-entero-pancreatic neuroendocrine tumors MedDRA version: 20.0 Level: PT Classification code 10057270 Term: Neuroendocrine carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10057270 Term: Neuroendocrine carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: 90Y-Dotatoc(DOTA ¿ D ¿Phe-Tyr-OCTREOTIDE) Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Patients of both sexes aged over 18 years b) Patients with histologically documented diagnosis of GEP-NET candidates for surgery R0 or R2. c) Presence of a PET / CT with 68Ga-DOTATOC showing a significant uptake (> than the liver) of the tracer at the tumor (SSR-positive) d) Functionality marrow, liver, kidney and heart check with instrumental tests (ECG) and laboratory (blood count, creatinine, transaminases, gamma-GT, alkaline phosphatase, sodium and potassium) e) Signed informed consent f) a negative pregnancy test (blood dosage of beta HCG) not older than 7 days is required in women in premenopausal status Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: a) Patient history of malignant tumors with treatment ongoing except for basal cell carcinoma in situ and cervical cancer radically removed b) Known intolerance to medical contrast medium and / or previous anaphylactic shock c) Women who are pregnant or nursing, GEP-NET recurrence and considered inoperable

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the sensitivity and specificity of the probe to detect tumor areas that can picked up by the radiotracer, with the purpose to obtain information about the capability of the probe to detect tumor margins and lymph nodes potentially pathological.;Secondary Objective: ¿ Evaluation of minimal activity that should be given to the patient and establishment the procedure ¿ Rating of irradiation staff ¿ Optimization of the probe ¿ Clinical-laboratory evaluation (patient safety) ¿ Toxicity ;Primary end point(s): To develop a method that allows the complete resection not only for GEP-NETs but also of other isotypes tumor that express the somatostatin receptors.;Timepoint(s) of evaluation of this end point: Just after surgery we expect to obtain information regarding radioactivity emitted by the tumor revealed by a probe	—

Measure

Time frame

Main Objective: To assess the sensitivity and specificity of the probe to detect tumor areas that can picked up by the radiotracer, with the purpose to obtain information about the capability of the probe to detect tumor margins and lymph nodes potentially pathological.;Secondary Objective: ¿ Evaluation of minimal activity that should be given to the patient and establishment the procedure ¿ Rating of irradiation staff ¿ Optimization of the probe ¿ Clinical-laboratory evaluation (patient safety) ¿ Toxicity ;Primary end point(s): To develop a method that allows the complete resection not only for GEP-NETs but also of other isotypes tumor that express the somatostatin receptors.;Timepoint(s) of evaluation of this end point: Just after surgery we expect to obtain information regarding radioactivity emitted by the tumor revealed by a probe

—

Secondary

Measure	Time frame
Secondary end point(s): ¿ Evaluation of minimal activity that should be given to the patient and establishment the procedure ; ¿ Rating of irradiation staff; ¿ Optimization of the probe; ¿ Toxicity;Timepoint(s) of evaluation of this end point: 1 month after treatment; 1 month after treatment; 3-6 mesi; 3- 6 mesi	—

Countries

Italy

Contacts

Public ContactUFFICIO STUDI CLINICI E ATTIVITA' R

ISTITUTO EUROPEO DI ONCOLOGIA

ufficio.studiclinici@ieo.it0257489848

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026