A phase I study assessing the safety and performance of VB5-845D-800CW, an fluorescent agent, for the intraoperative detection of gastrointestinal cancer
Recruiting
- Conditions
- Colorectal and Gastrointestinal cancer
- Registration Number
- NL-OMON27469
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
.A.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
•Part A (healthy volunteers)
A maximum of sixteen (16) healthy volunteers will take part in this study.
Exclusion Criteria
•Part A (healthy volunteers)
A maximum of sixteen (16) healthy volunteers will take part in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Healthy volunteers<br /><br>•To determine safety and tolerability of a single dose of VB5-845D-800CW in healthy volunteers.<br /><br>Patients<br /><br>•To assess safety of different doses of a single i.v. injection of VB5-845D-800CW.<br>
- Secondary Outcome Measures
Name Time Method Healthy volunteers<br /><br>•To determine the pharmacokinetics of VB5-845D-800CW by measuring fluorescence in blood and urine samples and evaluating the relationship of fluorescence in superficial tissue (skin) and mucous membranes (lips). <br /><br>•To determine the time of injection (and window) for part B<br><br /><br /><br>Patients<br /><br>•To define the optimal dose and injection time of VB5-845D-800CW for intraoperative imaging of esophageal/gastric- and rectosigmoid cancer using near-infrared fluorescence, defined as the dose with the largest difference in mean fluorescence intensity (MFI) between tumor and surrounding tissue<br /><br>•To assess the performance of VB5-845D-800CW in the intraoperative detection of esophageal/gastric- or rectosigmoid cancer by:<br /><br>oTumor-to-background ratio (TBR)<br /><br>oConcordance between fluorescent signal and tumor status and EpCAM expression of resected tissue<br>