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Abstract

Purpose:

Comprehensive cervical lymphadenectomy can be associated with significant morbidity and poor quality of life. This study evaluated the sensitivity and specificity of cetuximab-IRDye800CW to identify metastatic disease in patients with head and neck cancer.

Experimental Design: 

Consenting patients scheduled for curative resection were enrolled in a clinical trial to evaluate the safety and specificity of cetuximab-IRDye800CW. Patients (n = 12) received escalating doses of the study drug. Where indicated, cervical lymphadenectomy accompanied primary tumor resection, which occurred 3 to 7 days following intravenous infusion of cetuximab-IRDye800CW. All 471 dissected lymph nodes were imaged with a closed-field, near-infrared imaging device during gross processing of the fresh specimens. Intraoperative imaging of exposed neck levels was performed with an open-field fluorescence imaging device. Blinded assessments of the fluorescence data were compared to histopathology to calculate sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV).

Results:

Of the 35 nodes diagnosed pathologically positive, 34 were correctly identified with fluorescence imaging, yielding a sensitivity of 97.2%. Of the 435 pathologically negative nodes, 401 were correctly assessed using fluorescence imaging, yielding a specificity of 92.7%. The NPV was determined to be 99.7%, and the PPV was 50.7%. When 37 fluorescently false-positive nodes were sectioned deeper (1 mm) into their respective blocks, metastatic cancer was found in 8.1% of the recut nodal specimens, which altered staging in two of those cases.

Conclusions:

Fluorescence imaging of lymph nodes after systemic cetuximab-IRDye800CW administration demonstrated high sensitivity and was capable of identifying additional positive nodes on deep sectioning. 

Author information​

Rosenthal EL1, Moore LS2, Tipirneni K3, de Boer E4, Stevens TM5, Hartman YE2, Carroll WR2, Zinn KR6, Warram JM2.

1 Department of Otolaryngology, Stanford University, Stanford, California. ERosenthal@stanfordhealthcare.org.

2 Department of Otolaryngology, University of Alabama at Birmingham, Birmingham, Alabama.

3 Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.

4 Department of Surgery, University Medical Center Groningen University of Groningen, Groningen, the Netherlands.

5 Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama.

6 Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama.