At a glance
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A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective) Neck Dissection for Metastatic Lymph Node Identification in Patients With Head and Neck Cancer
In Brief
A Phase 2 clinical trial evaluating Panitumumab-IRDye800 and Lymphoseek for Head and Neck Squamous Cell Carcinoma and 2 related conditions. Completed, enrolled 3 participants across 1 site.
Detailed Summary
This phase 2 trial studies how well panitumumab-IRDye800 works in identifying head and neck cancer that has spread to the lymph nodes in patients with head and neck cancer. Panitumumab-IRDye800 may help surgeons to identify metastatic lymph nodes during surgical removal of the primary tumor and/or lymph nodes of the neck with equal or better accuracy than the current methods.
Study Details
Timeline
Interventions
Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy). Panitumumab dose is \< 1/12 of the therapeutic dose.
Local, peri-tomoral injection with 2 mCi Lymphoseek (99mTc Tilmanocept) (as 4 x 0.1 mL injections of Lymphoseek solution