Phase II Open-Label Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures
University of Alabama at Birmingham
Summary
The purpose of this study is to determine if panitumumab-IRDye800 is effective in identifying cancer, compared to surrounding normal tissue, and the further characterize the safety profile of this drug.
Description
Head and neck squamous cell carcinoma tumors can be difficult to visualize intraoperatively. Most primary oral cavity cancers and previously irradiated head and neck cancers require surgical resection for definitive treatment. Currently, tumor margins are determined intraoperatively by a combination of palpation, visual inspection, and microscopic assessment frozen tissue sections. Difficulty in assessing intraoperative tumor margins of primary head and neck cancers makes resection inexact -the incidence of involved or close surgical margins in head and neck cancer patients approaches 40% on h…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck 2. Diagnosis of any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed. 3. Planned standard of care surgery with curative intent for squamous cell carcinoma 4. Male or female patients age ≥ 18 years 5. Have life expectancy of more than 12 weeks 6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1 7. Have acceptable hematologic status, coagulation status, kidney function,…
Interventions
- DrugPanitumumab-IRDye800
single dose infusion of panitumumab-IRDye800CW
Location
- University of Alabama at BirminghamBirmingham, Alabama