Detection of metastasis in the lymph nodes with preoperative imaging and fluorescent light during the surgical procedure in patients with colon cancer

• Conditions: MedDRA version: 18.1Level: LLTClassification code 10009951Term: Colon cancer NOSSystem Organ Class: 100000004864; Colon Carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000304-96-NL
• Lead Sponsor: VU University Medical Center (VUmc)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-02
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Oral and written informed consent
-Age 18 years and older
-Colon cancer (T1-T2)
-Laparoscopic surgical resection of the tumour
-Regular pre-operative work-up

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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-Patients younger than 18 years
-Patients who are legally or mentally incapable or unable to give informed consent
-Gross lymph node involvement
-Invasion of the tumour in surrounding tissue
-Distant metastases
-T4 or metastatic disease discovered during intraoperative staging
-Contraindications to laparoscopic surgery
-Patients at higher risk for anaphylactic reactions
-Pregnancy
-Recent myocardial infarction
-Allergy for iodine
-Claustrophobia

Study & Design

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