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

Completed

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

• Registration Number: NL-OMON53524
• Lead Sponsor: Meander Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-10-10
• 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 confirmed 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>The primary outcome parameters are identification rate of SLN(s) or lymph node<br /><br>metastases with bevacizumab-800CW, defined as the number of patients in which a<br /><br>SLN or lymph node metastasis was detected due to fluorescence during surgery<br /><br>and/or pathology assessment divided by the total number of procedures.<br /><br>Furthermore the rate of adverse events related towards bevacizumab-800CW will<br /><br>be measured. This is defined as the number of adverse events related towards<br /><br>bevacizumab-800CW/total number of procedures.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters include: amount of fluorescence in lymph node<br /><br>metastases compared to lymph node without metastases, false-negative SLNs,<br /><br>true-negative SLNs, sensitivity, upstaged patients, aberrant lymph node status,<br /><br>accuracy, negative predictive value and number of SLNs identified. </p><br>