Technology of the radioisotopes for the intra-operative identification of the sentinel node in the premature gastric cancer. Clinical study of feasibility in order to improve the treatment and prognosis - ND

• Conditions: gastric cancer; MedDRA version: 6.1Level: PTClassification code 10061968

• Registration Number: EUCTR2006-001503-10-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- Tis and T1 Early Gastric Cancer - T2 neoplasia that invades the muscular or serosa tunica Could be included in the study early tumors deal in inadequate way for endoscopica way to subject to surgical participation of radicalization
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- T3 tumor emerging to the serosa without invasion of contiguous organs - T4 tumor that infiltrates adjacent structures - M1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the such clinical importance of methodical of intra-operative stage for the treatment of the premature gastric cancer.;Primary end point(s): Validation of the methodical;Secondary Objective: Realization of a diagnostic pre and intra-operating distance that uses the technology of the radioisotopes, for the identification of the metastases in the node in the premature gastric cancer. To guarantee the performance of one corrected operating procedure. To demonstrate to the high effectiveness accuracy and sensibility of the technology of the radioisotopes in the finding of the sentinel node in the premature gastric cancer. To demonstrate the determined superiority of the technology of the radioisotopes regarding that one of vital colouring for the identification of the sentinek node.