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

Description

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.

Conditions

Head and Neck Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Head and Neck Cancer
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford University, Stanford, California, United States, 94305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Andrei Iagaru,

Fred Baik, MD, PRINCIPAL_INVESTIGATOR, Stanford Universiy

Study Record Dates

2026-03