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Fluorescence-guided visualization of soft tissue sarcomas by targeting vascular endothelial growth factor-A: a phase 1 single-center clinical trial

Steinkamp, P. J., Pranger, B. K., Li, M., Linssen, M. D., Voskuil, F. J., Been, L. B., van Leeuwen, B. L., Suurmeijer, A. J. H., Nagengast, W. B., Kruijff, S. K., van Ginkel, R. J. & van Dam, G. M., 17-Jul-2020, In : Journal of Nuclear Medicine.

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Rationale: Resection of soft tissue sarcomas (STS) is accompanied by a high rate of tumor-positive surgical margins (14-34%), which potentially leads to decreased disease-free survival. Vascular Endothelial Growth Factor-A (VEGF-A) is overexpressed in malignant tumors, including STS, and can be targeted with bevacizumab-800CW during fluorescence-guided surgery for real-time tumor detection. In this phase 1 clinical trial, we determined the feasibility, safety and optimal dose of bevacizumab-800CW for fluorescence-guided surgery (FGS) in STS for in- and ex vivo tumor detection. Methods: Patients with a histopathologically diagnosis of STS were included. In the dose-escalation phase, patients received bevacizumab-800CW intravenously 3 days prior to surgery (10, 25 and 50 mg, n = 8). In the subsequent dose-expansion phase, 7 additional patients received bevacizumab-800CW at the optimal dose. Fluorescence images in- and ex vivo were obtained during all stages of standard of care. The optimal dose was determined by calculating in- and ex vivo Tumor-to-Background ratios (TBR) and correlating these results with histopathology. Results: Fifteen patients with STS completed this study. All tumors could be visualized during in- and ex vivo imaging. The optimal bevacizumab-800CW dose proved to be 10 mg with a median in vivo TBR of 2.0 (±0.58) and an ex vivo TBR of 2.67 (±1.6). All seven tumor-positive margins could be observed real-time after surgical resection. Conclusion: FGS using 10 mg bevacizumab-800CW is feasible and safe for intra-operative imaging of STS, potentially allowing tumor detection and margin assessment during surgery. An additional follow-up phase II study is needed to confirm the diagnostic accuracy.

Original languageEnglish
JournalJournal of Nuclear Medicine
Publication statusE-pub ahead of print - 17-Jul-2020

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