A phase I/II Study to Evaluate the Safety and Feasibility of Dual-modality imaging using Indium-111-DOTA-labetuzumab-IRDye800CW in patients with Peritoneal Carcinomatosis of Colorectal Origi
Recruiting
- Conditions
- Colo-rectal Peritonitis Carcinomatosa100346521002747610017998
- Registration Number
- NL-OMON45898
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 29
Inclusion Criteria
Clinical diagnosis of peritoneal carcinomatosis of colorectal origin.
Scheduled for cytoreductive surgery and HIPEC.
Age over 18 years
Signed informed consent
Exclusion Criteria
Any medical condition present that in the opinion of the investigator will affect patients* clinical status.
Administration of a radionuclide within 10 physical half- lives prior to study enrollment
Pregnancy or lactation
Very high (>500 ng/ml) serum CEA levels
Immunohistochemically proven non-CEA expressing primary tumor (if analyzed in primary tumor resection specimen)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the feasibility, accuracy and safety of preoperative SPECT/CT and<br /><br>intraoperative fluorescence imaging after administration of<br /><br>111In-labetuzumab-IRDye800CW in patients with PC of colorectal origin who will<br /><br>undergo cytoreductive surgery and HIPEC. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess whether additional malignant lesions can be visualised by<br /><br>fluorescence imaging after cytoreductive surgery, to assess the correlation<br /><br>between localization of the dual-labeled antibody and CEA expression in tumor<br /><br>and healthy tissue, and to determine the gross blood clearance of<br /><br>111In-labetuzumab-IRDye800CW in patients.</p><br>