Colorectal peritoneal metastases (colorectal PM)
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
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 colorectal PM; 3) Scheduled to undergo CRS+HIPEC in the UMCG as part of standard care for colorectal PM; 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 birth control during the trial and for three 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 CRS+HIPEC confirmed by imaging (CT/PET); 2) Has been injected with another Investigational Medicinal Product (IMP) within the past month; 3) 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 five 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 subscribed or not-subscribed medication 14 days before tracer administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of fluorescent signal levels (defined as TBR) per dose group, consisting of the difference in signal levels betweencolorectal PM and normal benign surrounding tissue. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 colorectal PM | — |
Countries
Netherlands
Outcome results
None listed