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

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

The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell Carcinoma.

The secondary objective is to compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to Day of Surgery versus conventional local injection with an optical dye at the time of surgery.

Study Overview

• Status: Suspended
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: 111I-n panitumumab; Procedure: Single photon emission computed tomography/computed tomography (SPECT/CT) scans

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
• 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 a cN0 or cN1 disease. Clinical N1 disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging.
• Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
• Hemoglobin ≥ 9 gm/dL
• White blood cell count > 3000/mm3
• Platelet count ≥ 100,000/mm3
• 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.
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 111-In panitumumab; The study drug (111In panitumumab) 5 mCi, allowable range 4.5 to 5.5 will be administered on Day 0, and subjects will undergo one 111In panitumumab SPECT/CT imaging anytime between Day 1 and Day of Surgery. Subjects will undergo surgical resection after infusion of 111In panitumumab.	Drug: 111I-n panitumumab; Imaging Agent; Procedure: Single photon emission computed tomography/computed tomography (SPECT/CT) scans; Day 1 to 5 (Day of Surgery inclusive)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the safety of 111In panitumumab as a molecular imaging agent in patients with HNSCC.	Number of CTCAE v5.0 Grade 2 or higher adverse events by Day 15 determined that are significant, definitely or probably related to 111In panitumumab. Safety data will be summarized by grade, severity, and type.	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare sensitivity of systemic 111In panitumumab versus conventional local optical dye	Sensitivity of systemic 111In panitumumab of identifying sentinel lymph nodes versus sensitivity of conventional local optical dye in identifying sentinel lymph nodes using histopathology will be compared	10 days after surgery
Compare specificity of systemic 111In panitumumab versus conventional local optical dye	Specificity of systemic 111In panitumumab of identifying sentinel lymph nodes versus specificity of conventional local optical dye in identifying sentinel lymph nodes using histopathology will be compared	10 days after surgery

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Fred Baik, MD, Stanford Universiy

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Panitumumab
• Other Study ID Numbers: IRB-58398; ENT0083 (Other Identifier: OnCore); NCI-2021-05694 (Registry Identifier: National Cancer Institute: Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No