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

Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma

This study is testing a new imaging method to see if it can better find and measure head and neck cancer tumors compared to the usual imaging technique.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Drugs / interventions: panitumumab
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT05183048 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a biopsy-confirmed diagnosis of head and neck squamous cell carcinoma who are scheduled for surgical resection and are clinically node negative.

Not a fit: Patients who have received investigational drugs within 30 days prior to the study or those with significant comorbidities affecting their eligibility may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more precise tumor localization, potentially improving surgical outcomes for patients with head and neck cancer.

How similar studies have performed: While this approach is novel in the context of head and neck cancer imaging, similar imaging techniques have shown promise in other cancer types.

Eligibility criteria

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 this trial is running

Birmingham, Alabama

• UAB — Birmingham, Alabama, United States (Recruiting)

Study contacts

• Principal investigator: Suzanne Lapi, PhD — University of Alabama at Birmingham
• Study coordinator: Sebastian Eady, BS

Conditions Head and Neck Squamous Cell Carcinoma