Clinical Trials Logo
  1. Home
  2. Neuroendocrine Tumors
  3. NCT04296149
  4. Details
NCT04296149 Clinical Trial

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

Neuroendocrine Tumors Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04296149
Other study ID # IEO 0388
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 16, 2017
Est. completion date December 31, 2019

Study information
Verified date March 2020
Source European Institute of Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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 information / eligibility
Status Completed
Enrollment 5
Est. completion date December 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- negative PET/CT; pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Italy Chiara Maria Grana Milano

Sponsors (1)
Lead Sponsor Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 years
See also
  Status Clinical Trial Phase
Completed NCT01218555 - Study of Everolimus (RAD001) in Combination With Lenalidomide Phase 1
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Withdrawn NCT04614766 - A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors Phase 1/Phase 2
Recruiting NCT05556473 - F-Tryptophan PET/CT in Human Cancers Phase 1
Completed NCT03273712 - Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC) Phase 2
Recruiting NCT05636618 - Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors Phase 1/Phase 2
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Completed NCT02815969 - The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors
Completed NCT02441062 - Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors Phase 2
Active, not recruiting NCT02174549 - Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer Phase 1/Phase 2
Completed NCT02132468 - A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers Phase 2
Completed NCT02134639 - PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation N/A
Recruiting NCT01201096 - Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors (NEO-LEBE) N/A
Terminated NCT01163526 - Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies N/A
Completed NCT01099228 - Combination Targeted Radiotherapy in Neuroendocrine Tumors N/A
Completed NCT00171873 - Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut Phase 3
Active, not recruiting NCT05077384 - Open-label Study of Surufatinib in Japanese Patients Phase 1/Phase 2
Active, not recruiting NCT04544098 - Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver Early Phase 1
Active, not recruiting NCT02736500 - Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors Phase 1/Phase 2