Targeted dual-imaging helper for head and neck cancer 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 is a phase 1, single-arm study to assess the safety and feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 as dual-modality imaging tools during tumor resection and neck dissection for head and neck squamous cell carcinoma. Participants receive Pan800 1–2 days before surgery and [18F]NOTA-ABY-030 on the day of surgery to help visualize cancer tissue. The trial compares imaging results with final pathology to gauge accuracy in detecting tumors and nodal disease. No control group is used; the focus is on safety, tolerability, and imaging performance. Illnesses, medications, and surgical statuses are closely monitored to ensure patient safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Subjects diagnosed with any T stage or N stage squamous cell carcinoma and any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed.
3. Have acceptable hematologic status, kidney function, and liver function including the following clinical results:

   * Hemoglobin ≥ 9 gm/dL
   * White blood cell count \> 3000/mm3
   * Platelet count ≥ 100,000/mm3
   * Serum creatinine ≤ 1.5 times upper reference range
   * Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
2. Evidence of QTcF prolongation on ECG within 30 days of pan800 administration (greater than 480 ms).
3. History of infusion reactions to monoclonal antibody therapies.
4. History of allergies to iodine.
5. Pregnant or breastfeeding.
6. Magnesium or phosphorus lower than the normal institutional values and the patient is symptomatic.
7. Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
8. Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
9. Severe renal disease or anuria.

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Makenna Brown
• Email: makenna.l.brown@vumc.org
• Phone: 6154214370

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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.