RecruitingPhase 1NCT05901545

Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

30 participants

Start Date

Aug 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a radioactive imaging agent — labeled with indium-111 and attached to panitumumab, an antibody that targets cancer cells — to see if it can better detect whether head and neck cancer has spread to lymph nodes, helping surgeons decide which lymph nodes to remove. **You may be eligible if...** - You are 19 or older - You have confirmed squamous cell carcinoma of the head and neck - Your lymph nodes appear negative or suspicious on imaging (not clearly positive) - You are scheduled for standard surgical removal of neck lymph nodes - Your blood counts, kidney, and liver function are in acceptable ranges **You may NOT be eligible if...** - You have had a recent heart attack, stroke, or uncontrolled heart failure within the past 6 months - You have a history of infusion reactions to similar antibodies - You have known distant metastases (cancer that has spread to other organs) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPanitumumab

Given by IV

OTHERIndium In 111 Panitumumab

Given by IV

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT/CT

PROCEDUREComputed Tomography

Undergo SPECT/CT

PROCEDURESurgical Procedure

Undergo standard of care surgery

OTHERImaging agent

Receive local injection of optical dye

PROCEDUREIntraoperative Imaging

Undergo Intraoperative Imaging

PROCEDURENear Infrared Imaging

Undergo Near Infrared Imaging

PROCEDUREElectrocardiography

Undergo Electrocardiography

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

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NCT05901545


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