Phase 2 indocyanine green (NIR fluorescent dye tracer) fluorescence-guided sarcoma surgery trial.

City of Hope Medical Center is running this randomized, parallel-assignment Phase 2 trial testing whether fluorescence-guided surgery can lower the unexpected positive margin rate versus standard sarcoma resection. Patients are randomized to (1) standard-of-care curative-intent resection or (2) indocyanine green (ICG) given IV 12–24 hours pre-op followed by intraoperative near-infrared fluorescence imaging to help distinguish tumor from surrounding tissue. ICG’s functional “MOA” here is as a bloodborne NIR fluorophore that preferentially highlights tumor/altered permeability tissue and can be detected by a fluorescence camera; it is not a tumor-targeted drug, but a surgical-visualization agent. Eligible patients have intermediate- to high-grade, resectable sarcoma (all ages), excluding recurrent disease and intracranial, retroperitoneal, or visceral locations. Today’s care is wide surgical excision aiming for negative margins (often with radiation and/or systemic therapy depending on subtype and grade); this trial’s angle is a practical, scalable imaging add-on intended to reduce re-operations and local recurrence risk driven by margin positivity.