Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Intravenous Bevacizumab-800CW

NCT05497726 | Completed DMC

• 2 other identifiers: R21.1172021-006796-41
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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 intravenous administration.

Conditions

Colorectal Neoplasms; Colon Neoplasm; Sentinel Lymph Node; Fluorescence

Keywords

Sentinel lymph node; Colon cancer; Fluorescence; bevacizumab-800CW; bevacizumab-IRdye

Outcome Measures

Primary Outcomes (2)

• Feasibility of SLN(s) or lymph node metastases with intravenous bevacizumab-800CW

  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. If no lymph node metastases are present in the five patients, the study could still be a success since lymph nodes may contain fluorescence which is often in lower quantities than in lymph nodes containing metastases. 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.

  During surgery

• Safety of SLN(s) or lymph node metastases with intravenous bevacizumab-800CW

  The rate of adverse events related to bevacizumab-800CW (injection) will be measured. This is defined as the number of adverse events related towards bevacizumab-800CW/total number of procedures.

  Measured till 90 days after surgery

Secondary Outcomes (9)

• Amount of fluorescence in lymph node metastases compared to lymph node without metastases

  3 months (After examination by the Oddysey flatbed scanner)

• False-negative SLNs

  3 months (after pathological examination)

• True-negative SLNs

  3 months (after pathological examination)

• Sensitivity

  3 months (after pathological examination)

• Upstaging

  3 months (after pathological examination)

Study Arms (1)

Sentinel lymph node detection using intravenous bevacizumab-800CW

EXPERIMENTAL

Sentinel lymph node detection using intravenous bevacizumab-800CW

Procedure: Sentinel lymph node detection using intravenous bevacizumab-800CW

Interventions

Sentinel lymph node detection using intravenous bevacizumab-800CW PROCEDURE

Sentinel lymph node detection using intravenous bevacizumab-800CW

Sentinel lymph node detection using intravenous bevacizumab-800CW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Oral and written informed consent (IC)
• Aged 18 years and older
• Patients with pathologically confirmed and/or suspected cT1-3N0-2M0 colon carcinoma.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Meander Medical Center: lead

Study Sites (1)

Meander Medisch Centrum

Amersfoort, Utrecht, 3813TZ, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Esther Consten, prof. dr.

  Meander Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Model Details: This is a single-centre, open-label, non-randomized cohort safety and feasibility study.

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 11, 2022
• Study Start: January 27, 2023
• Primary Completion: July 10, 2023
• Study Completion: October 10, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

NL (1)