There is a need for better visualization of resection margins during surgery for soft tissue sarcoma. Optical molecular imaging of soft tissue sarcoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in soft tissue sarcoma versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling soft tissue sarcoma visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (10, 25 or 50mg) to detect soft tissue sarcoma intraoperatively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
dose finding:10mg; 25mg; 50mg
University Medical Center Groningen
Groningen, Netherlands
Tracer detection
Determine if accumulation of the fluorescent tracer bevacizumab-800CW can be detected with an intraoperative near infrared camera system to identify soft tissue sarcoma tissue during surgery
Time frame: up to 6 months
Part 1: Dose finding
Identify two doses of the NIR antibody tracer conjugate that provide the best visualization of tumour tissue during surgery
Time frame: up to 6 months
Part 1: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To obtain information safety aspects of the tracer, side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR)
Time frame: up to 6 months
Part 2: Optimal dose
Define which of the two doses of conjugate identified in part 1 is the optimal dose for further development in a phase II trial
Time frame: up to 6 months
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