Fluorescence Imaging in Sentinel Lymph Node Biopsy for Head and Neck Cancer

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 50
• Participant gender: All

Summary

Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs). Currently, this requires switching from near-infrared light to white light to be able to identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no system has been studied specifically for head and neck sentinel lymph node biopsies using a hands free goggle system that can visualize white light (normal surgical visualization) and nearinfrared light (ICG fluorescence) simultaneously. This technology may have implications on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and cutaneous tumors. Secondarily, this may reduce operative costs by decreasing the amount of time required to perform the SLNB procedure.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Last Updated: 2017-09-26

Criteria

Inclusion Criteria:

• Adults aged 18 years or older will be considered eligible.

• Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma, that are candidates for sentinel lymph node biopsy.

*Newly diagnosed with clinically node negative head and neck cancer being staged with sentinel lymph node biopsy.

• Not pregnant or breast feeding.

• Able to understand and willing to sign an IRB-approved written informed consent document.

• Able to understand written or spoken English.

Exclusion Criteria:

• History of allergy to iodide drugs or shellfish (iodine allergy)

• Pregnant or breast feeding

• Do not fit age criteria

• Prisoners

• Unable to provide written consent

• Contraindications for surgery

*Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the head and neck, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Receiving any other investigational agents