Clinical trial · Interventional
Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW.
A Pilot Study to Assess the Safety and Feasibility of Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW.
NCT05498051CI-TRIAL-00067860IBIZA-1completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective study aims to assess the safety and feasibility of lymph node identification using bevacizumab-800CW in patients with cT1-3N0-2 tumours, using peritumoral submucosal injections
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Fluorescence | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel lymph node identification | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentinel lymph node detection after submucosal bevacizumab-800CW injection
- description
- Therefore this prospective study aims to assess the safety and feasibility of lymph node identification using bevacizumab-800CW in patients with cT1-3N0-2 tumours, using peritumoral submucosal injections.
- interventionNames
- Procedure: Sentinel lymph node identification
Primary outcomes (2)
- measure
- Identification rate of SLN(s) or lymph node metastases
- timeFrame
- During surgery
- description
- Defined as the number of patients in which a SLN or lymph node metastases were detected due to fluorescence during surgery and/or pathology assessment divided by the total number of procedures. We conclude that the study is a feasible if: * We are to detect fluorescence in lymph nodes in 3 out of 5 patients (regardless of the presence of metastases) * And/or we are able to detect lymph node metastases with fluorescence, or if fluorescence is higher in lymph node metastases compared to tumour-negative lymph nodes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Oral and written informed consent (IC) * Aged 18 years and older * Patients with 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 it's components (Trehalose dehydrate, sodium phosphate, polysorbate 20, water for injections)
References
Publications (0)
Data not yet available
No reference posted for this study.