NL-OMON51885
Not yet recruiting
Not Applicable
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 - SELECT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal peritoneal metastases (colorectal PM)
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 13
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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;
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.
Outcomes
Primary Outcomes
Not specified
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