EUCTR2021-006796-41-NL
Active, Not Recruiting
Phase 1
A pilot study to assess the safety and feasibility of fluorescent sentinel lymph node identification in colon carcinoma using intravenous bevacizumab-800CW - IBIZA-2(pilot)
Meander Medical Centre0 sites5 target enrollmentJuly 13, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Colon carcinoma
- Sponsor
- Meander Medical Centre
- Enrollment
- 5
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Oral and written informed consent (IC)
- •\- Aged 18 years and older
- •\- Pathologically confirmed and/or suspected cT1\-3N0\-2M0 colon carcinoma
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 2
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 3
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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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