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Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer | Clinical Trials | Clareo Health

SUSPENDEDPHASE1

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

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

NCT04840472•Stanford University

Summary

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Stanford University

Stanford, California, United States

Key Dates

Start Date

March 30, 2021

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

December 24, 2025

Enrollment

ESTIMATED participants

Conditions

Head and Neck Cancer

Interventions

111I-n panitumumab

DRUG

Single photon emission computed tomography/computed tomography (SPECT/CT) scans

PROCEDURE

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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