Using a new imaging method to locate head and neck cancer tumors

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 pilot clinical study aims to evaluate the effectiveness of Zirconium-89 (89Zr) panitumumab in accurately identifying the size and location of primary tumors in patients with head and neck squamous cell carcinoma (HNSCC) compared to the standard imaging method, Fludeoxyglucose (18F-FDG). The study involves an open-label, single-center, non-randomized approach where participants will receive both imaging techniques prior to their scheduled surgical resection. Patients will be screened for eligibility based on specific clinical criteria, and those who qualify will undergo a series of imaging and infusion procedures. The results will help determine if the new imaging method provides better localization of tumors without altering the clinical treatment plan.

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. Subjects newly diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection.
3. Subjects are to be staged clinically and radiographically node negative (cN0)
4. Planned standard of care surgery with curative intent for squamous cell carcinoma
5. Age \> 18 years
6. Have acceptable hematologic status, coagulation status (11 to 13.5 seconds. international normalized ratio (INR) of 0.8 to 1.1), kidney function, and liver function including the following clinical results:

   1. Hemoglobin ≥ 9 gm/dL
   2. White blood cell count ≥ 3000/mm3
   3. Platelet count ≥ 100,000/mm3
   4. Serum creatinine ≤ 1.5 times upper reference range
   5. alanine transaminase (ALT) (SGPT) 7-56 units/liter, aspartate aminotransferase (AST) (SGOT) 5-40 units/liter.

Exclusion Criteria:

1. Received an investigational drug within 30 days prior to the first dose of \[89Zr\]panitumumab.
2. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
3. Previous HNSCC resection.
4. History of infusion reactions to monoclonal antibody therapies.
5. Pregnant or breast-feeding women.
6. Magnesium (\<1.7 mg/dL) or potassium (\<3.6 mmol/L) lower than the normal institutional values.
7. Subjects receiving Class I-A (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
8. Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
9. Severe renal disease or anuria (Creatinine within normal institutional limits OR Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels).
10. Known hypersensitivity to panitumumab or any of its components.
11. Weight over 350 lbs., due to the scanner bore size.
12. Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos).

Where it's running

• UAB
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Suzanne Lapi, PhD — University of Alabama at Birmingham
• Study coordinator: Sebastian Eady, BS
• Email: smeady@uabmc.edu
• Phone: 204-996-2636

Similar studies

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

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  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Hebei, Hebei · NCT07906587

• ICG with near-infrared imaging to visualize head and neck cancer during surgery

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• Online Sharing for Head & Neck Cancer Support

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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.