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Intraoperative identification of colonic tumor site using near infrared indocyanine green-induced endosopic fluorescence imaging system

ABSTRACT: Interventions: 0.5 ml ICG was injected the mucosa into the submucosal space of the bowel wall at just the distal side of the tumor preoperative endoscopically. We identified the colonic tumor site in the PINPOINT Endoscopic Fluorescence Imaging System, in which NIR fluorescence is superimposed in pseudo-color (green) on a white light image. Primary outcome(s): The intraoperative visibility rate of tumor site Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2636552 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: The Clinical Trial Application presents information related to the monoclonal antibody bevacizumab labeled with the fluorescent dye IRDye800CW as injection. The injection vial contains 5.0 mg bevacizumab-IRDye800CW in 0.9% NaCl. Patients will receive a single dose bevacizumab-IRDye800CW of 4.5 mg by intravenous administration, according to the IMPD. Bevacizumab (Avastin, Roche) is a recombinant, high affinity, humanized IgG1 monoclonal antibody with specific affinity for VEGF. The infrared dye IRDye800CW (LI-COR Biosciences, Lincoln, NE, USA) is a fluorescent dye applicable for clinical use, produced by REGIS technologies. Conjugation of the fluorescent dye to bevacizumab, purification and formulation will be performed at the department of hospital and clinical pharmacy of the UMC Groningen. The new tracer bevacizumab-IRDye 800CW has been evaluated preclinical in tumor bearing nude mice and an extended single microdose toxicity study has been performed by NOTOX, which did not show toxicity (more information can be found in the IMPD). Patients will receive a single dose of 4.5 mg microdosing of bevacizumab-IRDye800CW, compared to a therapeutic dose of 5-10 mg/kg every two weeks. Recently, 26 renal cancer patients underwent repeated 4.5 mg 89Zr-bevacizumab administrations and imaging at baseline, 4 weeks and 6 weeks at the UMCG (NCT00831857). One patient reported nausea, redness of the face and cold extremities for 24 hours after the third tracer injection but continued bevacizumab treatment (10 mg/kg) without adverse events. No toxicity was observed in the first five breast cancer (NL37479.042.11) using bevacizumab-IRDye800CW. Based on these we do not expect toxicity of the single micro-dose administration of bevacizumab-IRDye800CW. Off course, patients will be ext Primary outcome(s): Determining the feasibility of pre-operative detection of peritoneal carcinomatosis of colorectal origin by intraoperative fluorescence imaging using the VEGF-targeting optical agent bevacizumab-IRDye800CW as confirmed by ex vivo standard histopathological and immunohistochemical analyses for the presence of tumour cells and VEGF-A expression in excised tumor tissue en fluorescence microscopy for the bevacizumab-IRDye800CW tracer Study Design: N/A: single arm study, Open (masking not used), N/A , unknown, Other

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Intraoperative identification of colonic tumor site using near infrared indocyanine green-induced endosopic fluorescence imaging system

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