Validation of a scintigraphic method for localyzing small colonic lesions prior to minimally invasive resectio

Conditions: colon cancer
MedDRA version: 14.1Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-005275-16-IT

Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Aged = 18 years - Able to provide written informed consent - Diagnosis of early (T1) colon cancer or of endoscopically removed colonic polyp, with malignant histology (infiltration of the submucosa) and requiring surgical radicalization - Colon cancer suitable for resection by minimally invasive surgery - Patient fit for robotic-assisted or standard laparoscopic colon resection - American Society of Anesthesiologists (ASA) physical status =3
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

Benign lesions of the colon or of the rectum above 12 cm from the anal verge - Benign or malignant diseases of the anal canal - Synchronous colorectal tumours requiring multi-segment surgical resection - Co-existent inflammatory bowel disease - Clinical or radiological evidence of metastatic spread - Concurrent or previous diagnosis of invasive cancer within 5 years that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer treated with curative intent are acceptable) - History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements - Pregnancy - Breast feeding - Participation in another colon cancer clinical trial relating to lesion mapping techniques