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 1 study
- Conditions
- Colorectal peritoneal metastases (colorectal PM)10027476
- Registration Number
- NL-OMON51885
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 13
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.
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Degree of fluorescent signal levels (defined as TBR) per dose group, consisting<br /><br>of the difference in signal levels<br /><br>betweencolorectal PM and normal benign surrounding tissue.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Correlation of the ex-vivo fluorescent signal in colorectal PM and normal<br /><br>tissue with histopathology and immunohistochemistry•<br /><br>Macroscopic and real-time quantification of the fluorescent signal from<br /><br>pathologically confirmed colorectal PM</p><br>