peritoneal carcinomatosis of colorectal cancer
Conditions
Interventions
The Clinical Trial Application presents information related to the monoclonal antibody bevacizumab labeled with the fluorescent dye IRDye800CW as injection. The injection vial contains 5.0 mg bevacizu
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Microscopic fluorescent signal levels observed and distribution in biopsy specimens (semi-quantitative). Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSARs). | — |
Contacts
Public ContactG.M. Dam, van
University Medical Center Groningen Department of Surgery / BioOptical Imaging Center Groningen
Outcome results
None listed