Fluorescence-guided imaging for resection margin evaluation in head and neck cancer patients using cetuximab-800CW: A quantitative dose-escalation studyVoskuil, F. J., de Jongh, S. J., Hooghiemstra, W. T. R., Linssen, M. D., Steinkamp, P. J., de Visscher, S. A. H. J., Schepman, K-P., Elias, S. G., Meersma, G-J., Jonker, P. K. C., Doff, J. J., Jorritsma-Smit, A., Nagengast, W. B., van der Vegt, B., Robinson, D. J., van Dam, G. M. & Witjes, M. J. H., 2020, In : Theranostics. 10, 9, p. 3994-4005 12 p.
Research output: Contribution to journal › Article › Academic › peer-review
Tumor-positive resection margins are present in up to 23% of head and neck cancer (HNC) surgeries, as intraoperative techniques for real-time evaluation of the resection margins are lacking. In this study, we investigated the safety and potential clinical value of fluorescence-guided imaging (FGI) for resection margin evaluation in HNC patients. We determined the optimal cetuximab-800CW dose by quantification of intrinsic fluorescence values using multi-diameter single-fiber reflectance, single-fiber fluorescence (MDSFR/SFF) spectroscopy.
Methods: Five cohorts of three HNC patients received cetuximab-800CW systemically: three single dose cohorts (10, 25, 50 mg) and two cohorts pre-dosed with 75 mg unlabeled cetuximab (15 or 25 mg). Fluorescence visualization and MDSFR/SFF spectroscopy quantification was performed and were correlated to histopathology.
Results: There were no study-related adverse events higher than Common Terminology Criteria for Adverse Events grade-II. Quantification of intrinsic fluorescence values showed a dose-dependent increase in background fluorescence in the single dose cohorts (p
Conclusion: A pre-dose of 75 mg unlabeled cetuximab followed by 15 mg cetuximab-800CW was considered the optimal dose based on safety, fluorescence visualization and quantification of intrinsic fluorescence values. We were able to use a lower dose cetuximab-800CW than previously described, while remaining a high sensitivity for tumor detection due to application of equipment optimized for IRDye800CW detection, which was validated by quantification of intrinsic fluorescence values.
|Number of pages||12|
|Publication status||Published - 2020|
- fluorescence-guided imaging, intrinsic fluorescence, MDSFR/SFF spectroscopy, cetuximab-800CW, head and neck cancer, DISEASE-SPECIFIC SURVIVAL, SURGICAL NAVIGATION, LOCAL RECURRENCE, SAFETY, ALPHA