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Head and Neck Squamous Cell CarcinomaDiagnostics and screeningBiologicalProcedurePhase 1

What this study is

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.

What's being tested

  • Panitumumab

    Intervention · BIOLOGICAL

  • Indium In 111 Panitumumab

    Intervention · OTHER

  • Single Photon Emission Computed Tomography

    Intervention · PROCEDURE

  • Computed Tomography

    Intervention · PROCEDURE

  • Surgical Procedure

    Intervention · PROCEDURE

    Undergo standard of care surgery

  • Imaging agent

    Intervention · OTHER

    Receive local injection of optical dye

  • Intraoperative Imaging

    Intervention · PROCEDURE

    Undergo Intraoperative Imaging

  • Near Infrared Imaging

    Intervention · PROCEDURE

    Undergo Near Infrared Imaging

  • Electrocardiography

    Intervention · PROCEDURE

    Undergo Electrocardiography

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood sample collection

Both Panitumumab and Indium In 111 Panitumumab

Given by IV

Both Single Photon Emission Computed Tomography and Computed Tomography

Undergo SPECT/CT

Study details

Sponsor
Vanderbilt-Ingram Cancer Center
Conditions
Head and Neck Squamous Cell Carcinoma · Recurrent Head and Neck Squamous Cell Carcinoma
Enrolling
30 people
Starts
2023-08-22
Est. completion
2029-11-30
Design
Open-label, single group, Phase 1
Record
View on ClinicalTrials.gov ↗