Sentinel lymph node identification in colon cancer using the hybrid tracer ICG- 99mTc-nanocoll

Phase 2

Completed

Conditions: Colon cancer
sentinel lymph node
10017943
10017991
10017998

Registration Number: NL-OMON46140

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Oral and written informed consent
Age 18 years and older
Preoperative tumor stage colon cancer (Tis-T1-T2)
Laparoscopic surgical resection of the tumor
Regular pre-operative work-up

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
- Tumours > 5 cm estimated during preoperative diagnostics
- T3 / 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
- Rectal carcinoma

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of patients upstaged with the SLN procedure </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Preoperative detection rate of SLNs by SPECT/CT scan<br /><br>- Adaptive value of preoperative localization of SLNs by SPECT/CT imaging<br /><br>during the surgical procedure.<br /><br>- Number of injection failures<br /><br>- Duration of SLN procedure<br /><br>- Implementation of the SLN procedure in the conventional surgical procedure<br /><br>- Adaptive value and capability of the SLN procedure for the surgeon<br /><br>- Adaptive value of gamma-probe in detection of the SLNs<br /><br>- Number and location of SLNs detected by NIR fluorescence imaging<br /><br>- Visualization of lymphatic vessels and the possibility of differentiation<br /><br>between first and second echelon lymph nodes.<br /><br>- Pathological status of the detected SLNs.<br /><br>- Optimale time-frame for SPECt-CT scan after 99mTc-nanocoll injection. </p><br>