Using panitumumab-IRDye800 to improve cancer visualization in head and neck surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of panitumumab-IRDye800 in distinguishing cancerous tissue from normal tissue during surgical procedures for head and neck squamous cell carcinoma. The approach involves administering the drug to patients scheduled for surgical resection, allowing for better intraoperative visualization of tumors. By improving the accuracy of tumor margin assessment, the study seeks to enhance surgical outcomes and reduce the incidence of incomplete tumor resections. The safety profile of panitumumab-IRDye800 will also be characterized throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
2. Diagnosis of any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
3. Planned standard of care surgery with curative intent for squamous cell carcinoma
4. Male or female patients age ≥ 18 years
5. Have life expectancy of more than 12 weeks
6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:

   1. Hemoglobin ≥ 9 gm/dL
   2. Absolute Neutrophil Count ≥ 1500
   3. White Blood Cell count \> 3000/mm3
   4. Platelet count ≥ 100,000/mm3
   5. Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
3. History of infusion reactions to any monoclonal antibody therapies
4. Women who are pregnant or breast-feeding
5. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
6. Magnesium or potassium lower than the normal institutional values
7. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
9. TSH \> 13 micro International Units/mL

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Anthony Morlandt, DDS MD — University of Alabama at Birmingham
• Study coordinator: Destiny Talley, RN
• Email: destinytaylor@uabmc.edu
• Phone: (205) 975-6169

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.