Actively Recruiting
Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer
Led by Vanderbilt-Ingram Cancer Center · Updated on 2026-03-05
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt-Ingram Cancer Center
Lead Sponsor
A
American Cancer Society, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) in identifying sentinel lymph nodes in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. This phase I trial focuses on detecting lymph node metastases, which greatly affect survival rates, by using a radioactive drug linked to an antibody that binds to tumor cells. The drug's uptake is visualized with SPECT/CT imaging to potentially improve lymph node detection compared to current methods. Participants receive a loading dose of panitumumab intravenously over 15 minutes, followed by an intravenous bolus of 111In-panitumumab on day 0. A SPECT/CT scan is performed between day 1 and the day of surgery (up to day 5). During standard surgery, patients receive a local injection of an optical dye and undergo intraoperative and near infrared imaging. Blood samples and electrocardiograms are collected at screening, on day 0, and on day 15 if needed. Throughout the study, researchers monitor safety by tracking adverse events up to 15 days after drug administration. They also compare the accuracy of 111In-panitumumab imaging with conventional local dye injection for sentinel lymph node detection. Participants are followed for safety and effectiveness assessments, including blood tests and imaging, until 15 days after the last dose. The total participation time is approximately two weeks.
CONDITIONS
Brief Title
Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Biopsy-confirmed squamous cell carcinoma of the head and neck
- Clinically staged as node-negative or clinically suspicious nodes
- Any T stage and any head and neck subsite scheduled for surgical resection
- Planned standard of care elective neck dissection
- Acceptable blood counts: hemoglobin at least 9 gm/dL, white blood cells over 3000/mm3, platelets at least 100,000/mm3
- Kidney function with serum creatinine not exceeding 1.5 times upper normal range
You will not qualify if you...
- Heart attack, stroke, uncontrolled heart failure, significant liver disease, or unstable angina within 6 months
- History of infusion reactions to monoclonal antibody therapies
- Allergy to iodine
- Pregnant or breastfeeding
- Low magnesium or potassium levels below normal institutional values
- Taking certain antiarrhythmic medications (Class IA or Class III)
- History or signs of lung inflammation or fibrosis
- Severe kidney disease or no urine production
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 days
Participants receive a loading dose of panitumumab intravenously over 15 minutes followed by an intravenous bolus of 111In-panitumumab on day 0. They then undergo a SPECT/CT scan between day 1 and the day of their standard of care surgery (up to day 5). During surgery, participants receive a local injection of optical dye and undergo intraoperative and near infrared imaging.
1 treatment day and imaging visits prior to surgery, 1 surgery visit
Duration - Up to 15 days after treatment
Participants are followed for safety monitoring with blood sample collection and electrocardiography up to 15 days after the last dose of study medication.
1 to 2 follow-up visits depending on ECG requirements
Trial Site Locations
Total: 1 location
1
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
N
Nicole Jones
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here