89Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in HNSCC

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

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-30

Study Completion Date

2027-12-31

Brief Summary

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The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous cell carcinoma (HNSCC).

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Detailed Description

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PRIMARY OBJECTIVE(S):

\- Determine the sensitivity and specificity of 89Zr-panitumumab for the detection of suspected metastatic lesions

SECONDARY OBJECTIVE(S):

\- Compare sensitivity and specificity of 18F-FDG-PET/CT and 89Zr-panitumumab-PET/CT for detection of suspected metastatic lesions

Conditions

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Head-and-neck Squamous Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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panitumumab 30 mg

Subjects will be given a 30mg of panitumumab

Group Type ACTIVE_COMPARATOR

Panitumumab

Intervention Type DRUG

Panitumumab 30mg will be given orally

89Zr-panitumumab IV

Subjects will be given 89Zr-panitumumab IV

Group Type EXPERIMENTAL

89Zr-panitumumab IV

Intervention Type DRUG

Subjects will be given a bolus of 1.0 mCi (range 0.8 - 1.2 mCi) of 89Zr-panitumumab before undergoing further standard of care diagnostic evaluation of the lesions

Interventions

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89Zr-panitumumab IV

Subjects will be given a bolus of 1.0 mCi (range 0.8 - 1.2 mCi) of 89Zr-panitumumab before undergoing further standard of care diagnostic evaluation of the lesions

Intervention Type DRUG

Panitumumab

Panitumumab 30mg will be given orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 19 years.
* 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. Subjects with recurrent disease or a new primary will be allowed.
* Must have standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions.
* Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results:

* Hemoglobin ≥ 9gm/dL
* White blood cell count \> 3000/mm3
* Platelet count ≥ 100,000/mm3
* Serum creatinine ≤ 1.5 times upper reference range
* PTT = 11.5 - 14.4 seconds
* INR = 0.9 - 1.2

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 other 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
* Known hypersensitivity to deferoxamine or any of its components

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No