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

NCT ID: NCT04840472

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

111I-n panitumumab

Intervention Type DRUG

Imaging Agent

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

Intervention Type PROCEDURE

Day 1 to 5 (Day of Surgery inclusive)

Interventions

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111I-n panitumumab

Imaging Agent

Intervention Type DRUG

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

Day 1 to 5 (Day of Surgery inclusive)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fred Baik, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Universiy

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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ENT0083

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2021-05694

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB-58398

Identifier Type: -

Identifier Source: org_study_id