A pilot study to assess the safety and feasibility of 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 - IBIZA-1(pilot)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51330

Enrollment

Registered

2022-07-12

Start date

2022-09-19

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colon carcinoma intestinal cancer

Interventions

1. Patients are identified at the outpatient clinic and asked for participation in the study. 2. Patients will be planned for laparoscopic/robot-assisted surgical colectomy according to standard of

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
1. Identification rate of SLN(s) or lymph node metastases with 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 / total number of procedure 2. Rate of adverse events related to bevacizumab-800CW (injection). Defined as the number of adverse events related towards bevacizumab-800CW / total number of procedures (n, %).	—

Measure

Time frame

1. Identification rate of SLN(s) or lymph node metastases with 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 / total number of procedure 2. Rate of adverse events related to bevacizumab-800CW (injection). Defined as the number of adverse events related towards bevacizumab-800CW / total number of procedures (n, %).

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Secondary

Measure	Time frame
3. Amount of fluorescence in lymph node metastases compared to lymph node without metastases 4. False-negative SLNs: The SLNs are negative whereas the non-sentinel nodes (NSNs) were positive (number). 5. True-negative SLNs: Both the SLNs and NSNs are negative (number). 6. Sensitivity: The number of patients with a positive SLN / the total number of node positive patients (n, %). 7. Upstaging: 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, %). 8. Aberrant lymph node status: The number of patients with aberrant lymph nodes, and the status of these lymph nodes considering micro- or macrometastases. 9. 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, %). 10. Negative predictive value (NPV): The number of true negative SLNs / (true negative + false negative SLNs). 11. Number of SLN identified: Number of SLN identified (number).	—

Measure

Time frame

3. Amount of fluorescence in lymph node metastases compared to lymph node without metastases 4. False-negative SLNs: The SLNs are negative whereas the non-sentinel nodes (NSNs) were positive (number). 5. True-negative SLNs: Both the SLNs and NSNs are negative (number). 6. Sensitivity: The number of patients with a positive SLN / the total number of node positive patients (n, %). 7. Upstaging: 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, %). 8. Aberrant lymph node status: The number of patients with aberrant lymph nodes, and the status of these lymph nodes considering micro- or macrometastases. 9. 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, %). 10. Negative predictive value (NPV): The number of true negative SLNs / (true negative + false negative SLNs). 11. Number of SLN identified: Number of SLN identified (number).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)