gastric cancer MedDRA version: 6.1 Level: PT Classification code 10061968
Conditions
Interventions
Product Name: Nanocoll
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Technetium 99mTc human albumin
Concentration unit: MBq megabecquerel(s)
Concentration t
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - T3 tumor emerging to the serosa without invasion of contiguous organs - T4 tumor that infiltrates adjacent structures - M1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed