Dataset Information

Detectie van tumorweefsel met behulp van Bevacizumab-IRDye800CW in combinatie met een optisch beeldvormingssysteem bij patiënten die de HIPEC procedure ondergaan, een haalbaarheidsstudie.

ABSTRACT: Interventions: Patients scheduled for a HIPEC procedure for peritoneal carcinomatosis of colorectal origin will be consented for this study. There will be three study related visits. During a screening visit (visit 1), eligibility will be evaluated and patient characteristics will be collected. During the second visit 4.5 mg of bevacizumab-‐IRDye800CW will be administered intravenously. The patient will then be observed for 1 hour post administration. One day after administration of the tracer (visit 3 one day before surgery) the patient is administered to the hospital as in the standard procedure, or the patient can stay after the tracer injection if this more convenient for the patient. During the HIPEC procedure the fluorescent imaging will be performed and data acquired. Primary outcome(s): Visualization of fluorescent tumor tissue confirmed by ex vivo immunohistochemistry or fluorescence microscopy of excised specimen. Study Design: N/A: single arm study, Open (masking not used), N/A , unknown, Other

DISEASE(S): Vegf-targeted Near-infrared Fluorescence Imaging In Peritoneal Carcinomatosis

PROVIDER: 18903 | 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

Dataset Information

Detectie van tumorweefsel met behulp van Bevacizumab-IRDye800CW in combinatie met een optisch beeldvormingssysteem bij patiënten die de HIPEC procedure ondergaan, een haalbaarheidsstudie.

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