RecruitingPhase 1NCT05747625

(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma

Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma


Sponsor

Eben Rosenthal

Enrollment

60 participants

Start Date

May 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 panitumumab \[89Zr panitumumab\]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer. Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions. Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT).


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special PET/CT scan with a new radioactive tracer (89Zr-Panitumumab) to better detect where cancer has spread in patients with head and neck squamous cell carcinoma. This tracer targets a protein on cancer cells and may reveal metastases that standard scans miss. **You may be eligible if...** - You are 19 or older - You have a confirmed diagnosis of squamous cell carcinoma of the head and neck - A previous scan showed uncertain or suspicious signs of cancer spread, or suspicious lymph nodes - You have adequate blood counts and kidney function **You may NOT be eligible if...** - You have had a heart attack, stroke, or unstable angina in the past 6 months - You have had allergic reactions to other monoclonal antibody treatments - You are pregnant or breastfeeding - You have interstitial pneumonitis, pulmonary fibrosis, or severe kidney disease - You are on certain heart rhythm medications (Class IA or III antiarrhythmics) - Your electrolyte levels (magnesium or potassium) are abnormally low Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPanitumumab

Given IV

DRUGZirconium Zr 89 Panitumumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT

PROCEDUREComputed Tomography

Undergo PET/CT

OTHERElectronic Health Record Review

Ancillary studies


Locations(1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

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NCT05747625


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