Detection of tumor tiSsue in pEritoneal metastases of coLorectal origin using a VEGF-targeted optical fluoresCent imaging tracer during diagnosTic laparoscopy: a single center phase I study
- Conditions
- Colorectal peritoneal metastases (PM)
- Registration Number
- NL-OMON25867
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 32
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1) Age = 18 years;
2) Patients with suspicions of colorectal PM determined during the HIPEC meeting;
3) Scheduled to undergo WL/FG-DLS in the UMCG as part of the standard preoperative work up for CRS and HIPEC;
4) WHO performance score of 0-2;
5) Mentally competent person who is able and willing to comply with study procedures;
6) Signed written informed consent;
7) For female subjects who are of childbearing potential are premenopausal with intact reproductive organs or are less than two years post-menopausal:
- A negative serum pregnancy test prior to receiving the tracer.
- Willing to ensure that she or her partner used effective contraception during the trial and for 3 months thereafter.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1) Clinically advanced stage of colorectal PM, not suitable for WL/FG-DLS confirmed by imaging (CT/PET);
2) Has been injected with another Investigational Medicinal Product (IMP) within the past six months;
3) Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years.
4) Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia) or myocardial infarction within 12 months prior to enrolment;
5) Significant renal (creatinine>110µmol/L) dysfunction;
6) Previous allergic reaction to bevacizumab;
7) Medical or psychiatric conditions that compromise the patient’s ability to give informed consent;
8) Pregnancy or breast feeding;
9) Any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Degree of fluorescent signal levels (defined as Tumor-to-Background Ratio [TBR]) per dose group, consisting of the difference in signal levels between colorectal PM and normal benign surrounding tissue.
- Secondary Outcome Measures
Name Time Method • Determining the safety profile of Bevacizumab-IRDye800CW by monitoring the number of (severe) adverse events (SAE/AEs) and suspected unexpected serious adverse reactions (SUSARs)<br><br>• Correlation of the ex-vivo fluorescent signal in colorectal PM and normal tissue with histopathology and immunohistochemistry<br> <br>• Macroscopic and real-time quantification of the fluorescent signal from pathologically confirmed PM