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

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.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

BIOLOGICAL

Panitumumab

Given by IV

OTHER

Indium In 111 Panitumumab

Given by IV

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

PROCEDURE

Computed Tomography

Undergo SPECT/CT

PROCEDURE

Surgical Procedure

Undergo standard of care surgery

OTHER

Imaging agent

Receive local injection of optical dye

PROCEDURE

Intraoperative Imaging

Undergo Intraoperative Imaging

PROCEDURE

Near Infrared Imaging

Undergo Near Infrared Imaging

PROCEDURE

Electrocardiography

Undergo Electrocardiography

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

• American Cancer Society, Inc.

  collaborator OTHER

• Vanderbilt-Ingram Cancer Center

  lead OTHER

Principal Investigators

• Eben Rosenthal, MD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-22

Primary Completion

2028-11-30

Completion

2029-11-30

FDA Drug

Yes

Countries

• United States

Study Locations