Colorectal peritoneal metastases (PM)
Conditions
Interventions
Single bolus of Bevacizumab-IRDye800CW (2.5 mg, 4.5 mg, 10 mg or 25 mg) intravenously.
Sponsors
UMCG
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • Determining the safety profile of Bevacizumab-IRDye800CW by monitoring the number of (severe) adverse events (SAE/AEs) and suspected unexpected serious adverse reactions (SUSARs) • Correlation of the ex-vivo fluorescent signal in colorectal PM and normal tissue with histopathology and immunohistochemistry • Macroscopic and real-time quantification of the fluorescent signal from pathologically confirmed PM | — |
Contacts
Public ContactJudith Hentzen
University Medical Center Groningen (UMCG)
Outcome results
None listed