Colorectal Neoplasms Clinical Trial
— IBIZA-1Official title:
A Pilot Study to Assess the Safety and Feasibility of Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW.
Verified date | July 2023 |
Source | Meander Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 5 |
Est. completion date | June 1, 2023 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Meander Medisch Centrum | Amersfoort | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Meander Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification rate of SLN(s) or lymph node metastases | 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. |
During surgery | |
Primary | Safety of SLN identification | 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 | Amount of fluorescence in lymph node metastases compared to lymph node without metastases | Fluorescence measured in the Oddysey flatbed scanner | 3 months (after fluorescence measurement) | |
Secondary | false-negative SLNs | The SLNs are negative whereas the non-sentinel nodes (NSNs) were positive (number). | 3 months (after pathological examination) | |
Secondary | true-negative SLNs | Both the SLNs and NSNs are negative (number). | 3 months (after pathological examination) | |
Secondary | sensitivity | The number of patients with a positive SLN / the total number of node positive patients (n, %). | 3 months (after pathological examination) | |
Secondary | upstaged patients | The number of patients with SLNs positive for micro- or macrometastases by serial slicing and IHC / the number of patients who were node negative by H&E examination (n, %). | 3 months (after pathological examination) | |
Secondary | aberrant lymph node status | The number of patients with aberrant lymph nodes, and the status of these lymph nodes considering micro- or macrometastases. | 3 months (after pathological examination) | |
Secondary | accuracy | (The total number of patients with a positive SLN + the number of patients with a true-negative SLN) / number of patients with an identified SLN (n, %). | 3 months (after pathological examination) | |
Secondary | negative predictive value | The number of true negative SLNs / (true negative + false negative SLNs). | 3 months (after pathological examination) | |
Secondary | number of SLNs identified | Number of SLN identified (number). | 3 months (after pathological examination) |
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