VEGF-Targeted Near-Infrared Fluorescence imaging in Peritoneal Carcinomatosis of Colorectal Origi
- Conditions
- peritoneal carcinomatosis of colorectal cancer
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Age >=18 years, patients with histopathological proven peritoneal carcinomatosis from colorectal origin who are scheduled to undergo the HIPEC procedure, patient is considered to be mentally and physically fit for the HIPEC procedure as judged by the responsible physician, WHO performance score 0-2, signed written informed consent.
Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years. Distance metastasis (liver / lungs), Medical or psychiatric conditions that compromise the patient¡¯s ability to give informed consent. Concurrent uncontrolled medical conditions. Pregnancy or breast feeding. Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the past 12 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determining the feasibility of pre-operative detection of peritoneal carcinomatosis of colorectal origin by intraoperative fluorescence imaging using the VEGF-targeting optical agent bevacizumab-IRDye800CW as confirmed by ex vivo standard histopathological and immunohistochemical analyses for the presence of tumour cells and VEGF-A expression in excised tumor tissue en fluorescence microscopy for the bevacizumab-IRDye800CW tracer
- Secondary Outcome Measures
Name Time Method Microscopic fluorescent signal levels observed and distribution in biopsy specimens (semi-quantitative).<br>Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSARs). <br>