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
327 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
This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography/computed tomography (SPECT/CT). SPECT/CT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.
CONDITIONS
Official Title
Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 219 years or older
- Biopsy-confirmed squamous cell carcinoma of the head and neck, clinically staged as node-negative or with suspicious lymph nodes
- Any T stage and any head or neck subsite, including recurrent or new primary disease
- Scheduled for surgical removal of cancer with elective neck dissection
- Acceptable blood, kidney, and liver function, including hemoglobin 29 gm/dL, white blood cell count > 3000/mm83, platelet count 100,000/mm83, and serum creatinine 1.5 times the upper reference range
You will not qualify if you...
- Heart attack, stroke, uncontrolled heart failure, significant liver disease, or unstable angina within 6 months before enrollment
- History of infusion reactions to monoclonal antibody therapies
- Allergies to iodine
- Pregnant or breastfeeding
- Low magnesium or potassium levels below normal institutional values
- Taking Class IA or Class III antiarrhythmic medications
- History or signs of interstitial pneumonitis or pulmonary fibrosis
- Severe kidney disease or absence of urine production
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
N
Nicole Jones
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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