|- candidate number||18054|
|- NTR Number||NTR4632|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jun-2014|
|- Secondary IDs||NL45588 EudraCT number 2013-≠003066-≠14|
|- Public Title||Detectie van tumorweefsel met behulp van Bevacizumab-IRDye800CW in combinatie met een optisch beeldvormingssysteem bij patiŽnten die de HIPEC procedure ondergaan, een haalbaarheidsstudie.|
|- Scientific Title||Intraoperative detection of tumor tissue in peritoneal carcinomatosis of colorectal origin using a VEGF-≠‐targeted Optical Fluorescent Imaging Tracer. A single center pilot study|
|- Healt Condition(s) or Problem(s) studied||Imaging, Tumour, Metastasis, Cancer|
|- 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||- 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 patientís 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2014|
|- planned closingdate||1-jul-2015|
|- Target number of participants||10|
|- Interventions||Patients scheduled for a HIPEC procedure for peritoneal carcinomatosis of colorectal origin will be consented for this study. There will be three study related visits. During a screening visit (visit 1), eligibility will be evaluated and patient characteristics will be collected. During the second visit 4.5 mg of bevacizumab-≠‐IRDye800CW will be administered intravenously. The patient will then be observed for 1 hour post administration. One day after administration of the tracer (visit 3 one day before surgery) the patient is administered to the hospital as in the standard procedure, or the patient can stay after the tracer injection if this more convenient for the patient. During the HIPEC procedure the fluorescent imaging will be performed and data acquired.|
|- Primary outcome||Visualization of fluorescent tumor tissue confirmed by ex vivo immunohistochemistry or fluorescence microscopy of excised specimen.|
|- Secondary outcome||Improvement of the detection rate of tumor tissue using Multispectral Fluorescence Reflectance Imaging (MFRI) by calculation the Peritoneal Carcinomatosis Index (PCI). |
|- Timepoints||day 1 tracer administration|
day 3 operation date
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. G.M. Dam, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G.M. Dam, van|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary||This project consist of the realization and clinical validation of intraoperative imaging of tumor tissue in peritoneal carcinomatosis of colorectal origin.
By applying a method to assess the extend of peritoneal dissemination of cancer through a novel targeted optical fluorescent imaging methodology staging and resection might be more optimal.|
VEGF-A is highly unregulated in colorectal tumortissue and can be targeted by using the VEGF antibody Bevacizumab (Avastin). Bevacizumab can be conjugated to the near infrared fluorphore, 800CW (bevacizumab-IRDye800CW).
In this study 10 patients scheduled for a HIPEC procedure will receive an IV injection with bevacizumab-IRDye800CW two days prior to the procedure.
During the procedure fluorescent tissue will be sampled and will be analyzed by an pathologist. The peritoneal cancer index wil be estimated using the fluorescent signal.
All procedures will be carried out in the University Medical Center Groningen
|- Main changes (audit trail)|
|- RECORD||8-jun-2014 - 4-jul-2014|