A pilot study to assess the safety and feasibility of fluorescent sentinel lymph node identification in colon carcinoma using submucosal bevacizumab-800CW

Completed

• Conditions: 10017990; 10017991; colon carcinoma; intestinal cancer

• Registration Number: NL-OMON51330
• Lead Sponsor: Meander Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

- Oral and written informed consent (IC)
- Aged 18 years and older
- Pathologically confinmed and/or suspected cT1-3N0-2M0 colon carcinoma

Exclusion Criteria

- Distant metastasis
- Suspicion of cT4 disease based on pre-operative assessment
- Metastatic or T4 disease discovered during intraoperative staging
- Pregnancy, lactation or a planned pregnancy during the course of the
study
- Previous colon surgery, excluding appendectomy.
- Contra-indication for laparoscopic/robotic surgery
- Inadequately controlled hypertension with or without current antihypertensive
medication.
- Within 6 months prior to inclusion: myocardial infarction, TIA, CVA,
pulmonary embolism, unstable angina pectoris, or uncontrolled chronic hepatic
failure.
- Regarding bevacizumab: Hypersensitivity to Chinese Hamster Ovary
(CHO) cell products or other recombinant human or humanised
antibodies. Or an allergy for its components (Trehalose dehydrate,
sodium phosphate, polysorbate 20, water for injections)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Identification rate of SLN(s) or lymph node metastases with<br /><br>bevacizumab-800CW, Defined as the number of patients in which a SLN or lymph<br /><br>node metastases were detected due to fluorescence during surgery and/or<br /><br>pathology assessment / total number of procedure<br /><br>2. Rate of adverse events related to bevacizumab-800CW (injection).<br /><br>Defined as the number of adverse events related towards bevacizumab-800CW /<br /><br>total number of procedures (n, %). </p><br>