Using dual imaging techniques to detect head and neck cancer

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 phase I trial evaluates the safety and effectiveness of two imaging techniques, indium In 111 panitumumab with SPECT/CT and panitumumab-IRDye800 fluorescence imaging, for detecting disease in patients with head and neck cancer. Patients will receive these imaging agents prior to undergoing standard surgical resection, allowing for enhanced visualization of tumor cells. The study aims to assess the sensitivity and specificity of these imaging methods in identifying subclinical disease and lymph nodes. Participants will be followed up 15 days after the intervention to monitor outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>= 19 years
* Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
* Subjects diagnosed with any T stage, 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
* Planned standard of care elective neck dissection for a cN0 or node- positive disease. Clinical node- positive disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging
* Hemoglobin \>= 9 gm/dL
* White blood cell count \> 3000/mm\^3
* Platelet count \>= 100,000/mm\^3
* Serum creatinine =\< 1.5 times upper reference range
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
* Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
* History of infusion reactions to monoclonal antibody therapies
* History of allergies to iodine
* Pregnant or breastfeeding
* Magnesium or potassium lower than the normal institutional values
* Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
* Severe renal disease or anuria
* Thyroid stimulating hormone (TSH) \> 13 micro international units/mL

Where it's running

• Vanderbilt University/Ingram Cancer Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Eben Rosenthal, MD — Vanderbilt University/Ingram Cancer Center
• Study coordinator: Nicole Jones
• Email: nicole.l.jones@vumc.org
• Phone: 615-936-2807

Similar studies

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

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• Combination treatment for advanced head and neck cancer

  This study is testing a new combination treatment for people with advanced head and neck cancer to see if it can boost their immune response and help fight the disease.

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• Using a radioactive drug to find cancer spread in head and neck patients

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  Recruiting Phase 1 Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT05901545

• Combination of immunotherapy and chemotherapy for head and neck cancer treatment

  This study is testing if combining an immunotherapy drug with chemotherapy before and after surgery can help people with head and neck cancer do better.

  Recruiting Phase 2 Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT05726370

• Cetuximab treatment for advanced head and neck cancer after immunotherapy

  This study is testing if the drug Cetuximab can help people with advanced head and neck cancer who didn’t respond to or couldn’t tolerate previous immunotherapy treatments.

  Recruiting Phase 2 Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT04375384

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.