Objective:

To evaluate the utility of intraoperative indocyanine green (ICG) fluorescence imaging for accurate characterization of tumor margins during sarcoma surgery.

Approach:

• Study Design: A prospective, observational, non-randomized clinical study involving 51 patients with biopsy-confirmed soft tissue or bone sarcoma scheduled for margin-negative surgery.
• ICG Administration: ICG was administered intravenously approximately 3 hours before surgery, with a weight-based dosage of 2.0 or 2.5 mg/kg.
• Intraoperative Evaluation: After tumor excision, a blinded evaluation of the tumor and tumor bed was conducted using the SPY-PHI Imaging System, with ICG findings not informing clinical decisions.
• Margin Assessment: The signal-to-background ratio (SBR) was calculated to assess margin status, and results were compared with surgeon assessments and final pathology.

Key Findings:

• The sarcoma-specific SBR-based ICG protocol detected positive margins with high sensitivity.
• The new ICG protocol demonstrated superiority over previously established breast cancer protocols.
• This study represents the largest report to date concerning ICG use in sarcoma surgery.

Interpretation:

The findings suggest that ICG fluorescence imaging may enhance the accuracy of margin assessment in sarcoma surgeries.

Limitations:

• The study was observational and non-randomized, which may affect the generalizability of the results.
• The sample size, while the largest to date, may still limit the robustness of the findings.

Conclusion:

A multicenter prospective clinical trial is warranted to further evaluate the efficacy of ICG in sarcoma surgery.

Sources:

• ClinicalTrials.gov