Intraoperative detection of tumor tissue in peritoneal carcinomatosis of colorectal origin using a VEGF-targeted Optical Fluorescent Imaging Tracer. A single centre Pilot study (HI-LIGHT study NL45588)

Completed

Conditions: colorectal
peritoneal carcinomatosis
10034652
10027656
10017998

Registration Number: NL-OMON40339

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

• Age >= 18 years.
• Patients with histopathological proven peritoneal carcinomatosis from colorectal origin who are scheduled to 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 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
<p>- Determination of sensitivity ands specificity data of the sampled (non-)<br /><br>fluorescent tissue acquired intraoperatively compared to standard<br /><br>histopathological examination for the presence of tumor tissue. (10 samples per<br /><br>patient).<br /><br>- Localization and (semi) quantification of a fluorescent signal of tumor<br /><br>tissue and surrounding tissue after post-processing of the in vivo required<br /><br>data.<br /><br>- In vivo NIR fluorescence quantification vs. ex vivo VEGF levels in biopsies<br /><br>and additional ex vivo analyses (using immunohistochemistry (IHC).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Improving the detection rate of peritoneal carcinomatosa using MFR imaging, for<br /><br>purposes of better staging by calculating the peritoneal carcinomatosis index<br /><br>(PCI) based on fluorescence detection</p><br>