ID
Bron
Verkorte titel
Aandoening
VEGF-Targeted Near-Infrared Fluorescence imaging in Peritoneal Carcinomatosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Visualization of fluorescent tumor tissue confirmed by ex vivo immunohistochemistry or fluorescence microscopy of excised specimen.
Achtergrond van het onderzoek
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
Onderzoeksopzet
day 1 tracer administration
day 3 operation date
Onderzoeksproduct en/of interventie
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.
Publiek
Department of Surgery / BioOptical Imaging Center Groningen <br>
G.M. Dam, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3612283
g.m.van.dam@chir.umcg.nl
Wetenschappelijk
Department of Surgery / BioOptical Imaging Center Groningen <br>
G.M. Dam, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3612283
g.m.van.dam@chir.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4514 |
NTR-old | NTR4632 |
CCMO | NL45588.042.13 |
OMON | NL-OMON40339 |