Recruiting
Phase 1

111In-Panitumumab

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT05901545

Conditions

Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Panitumumab

Indium In 111 Panitumumab

Single Photon Emission Computed Tomography

Computed Tomography

Surgical Procedure

Study Details

Brief 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

Study ID

NCT05901545

Start date

Aug 22, 2023

Status verified date

Feb, 2026

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 19 years.
  • Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck, clinically-staged as node-negative (cN0) or as clinically-suspicious node(s).
  • Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
  • Planned standard of care elective neck dissection for node-negative or node-positive disease.
  • Have acceptable hematologic status, kidney function, and liver function including the following clinical results:

  • Hemoglobin ≥ 9 gm/dL
  • White blood cell count > 3000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
  • History of infusion reactions to monoclonal antibody therapies
  • History of allergies to iodine
  • Pregnant or breastfeeding.
  • Magnesium or potassium lower than the normal institutional values.
  • Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
  • Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
  • Severe renal disease or anuria.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)

Patients receive loading dose of panitumumab IV over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.

Interventions

Panitumumab

Given by IV

Indium In 111 Panitumumab

Given by IV

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Computed Tomography

Undergo SPECT/CT

Surgical Procedure

Undergo standard of care surgery

Imaging agent

Receive local injection of optical dye

Intraoperative Imaging

Undergo Intraoperative Imaging

Near Infrared Imaging

Undergo Near Infrared Imaging

Electrocardiography

Undergo Electrocardiography

Biospecimen Collection

Undergo blood sample collection

Primary outcome measure

  • Incidence of adverse events grade 2 or higher [ Time Frame: Up to 15 days after administration of study drug ]

Central Contacts and Locations

Central contacts

Nicole Jones

615-936-2807nicole.l.jones@vumc.org

Locations

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Vanderbilt-Ingram Service Services for Timely Access

800-811-8480cip@vumc.org

Principal Investigator:

Eben Rosenthal, MD

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

Mar 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2026-03-05.